Value through Innovation27 July 2016

Clinical Study Results

  • MICARDIS ® - Hypertension
    Clinical Study Number 502.592
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk hypertensive Patients

    Study Document Trial synopsis 502.592_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.584
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    PRO-POWER: To evaluate the safety, efficacy, and P R O-tection of micardis 80mg /Micardis Plus 80/12.5mg from cardiOvascular risks in a 24 Weeks observational study in patients with essential hypErtension whom have at least one other known Risk factor

    Study Document Trial synopsis 502.584 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.582
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients (MicLife 24)

    Study Document Trial synopsis 502.582_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.465
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    PMS Assessing the Safety and Efficacy of Telmisartan in Patients with mild-to-moderate Essential Hypertension

    Study Document Trial synopsis 502.465_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.511
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Special survey on cerebrovascular and cardiovascular events under long-term use of Micardis® Tablets

    Study Document Trial synopsis 502.511 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.579
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Additional effect of a life style program on antihypertensive treatment with telmisartan

    Study Document Trial synopsis 502.579_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.236
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    DETAIL = Diabetics Exposed to Telmisartan And enalapIL: A randomised, double-blind, parallel-group comparison of the renal and antihypertensive effects of telmisartan and enalapril in subjects with mild to moderate hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy

    Study Document Trial synopsis 502.236_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.327
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (telmisartan 80 mg p.o. once daily) and Diovan® (valsartan 160 mg p.o. once daily) using Ambulatory Blood Pressure Monitoring (ABPM) in Patients with Mild to Moderate Hypertension After Missing One Dose

    Study Document Trial synopsis 502.327_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.339
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    An open, placebo run-in, multicentre studie to investigate the efficacy and safety (40 and 80 mg QD) in 3 strata of mild to moderate hypertensive patients with moderate, severe renal impairment or requiring maintenance hemodialysis. (ESPRIT Study = Efficacy and Safety in Patients with renal Impairment treated with Telmisartan).

    Study Document Trial synopsis 502.339_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.354
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Telmisartan Therapy for Hypertension in a Primary-Care Setting - A Canadian Observational Study

    Study Document Trial synopsis 502.354_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.376
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    MICADO - A prospective, randomised, double-blind, double-dummy trial to compare the efficacy of Micardis® (telmisartan) (80 mg p.o. once daily) and valsartan (160 mg p.o. once daily) in patients with mild-to-moderate hypertension after missing one dose using ambulatory blood pressure monitoring.

    Study Document Trial synopsis 502.376_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.385
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Pilot study: Inflammation and coronary artery disease. Role of AT1-Receptor Antagonism

    Study Document Trial synopsis 502.385_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.391
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5--10mg QD) in Patients with Mild-to-Moderate Hypertension using Ambulatory Blood Pressure Monitoring. PRISMA = Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril using ABPM

    Study Document Trial synopsis 502.391_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.392
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (telmisartan 40-80-80 mg, QD) and ALTACE® (ramipril 2.5-5-10 mg, QD) in Patients with Mild-to-Moderate Hypertension using Ambulatory Blood Pressure Monitoring. PRISMA II Study (Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril using ABPM)

    Study Document Trial synopsis 502.392_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.397
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, randomised, double-blind, double-dummy, forced-titration, multicentre, parallel group, one year treatment trial to compare MICARDIS® (telmisartan) 80 mg versus COZAAR® (losartan) 100 mg, in hypertensive type 2 diabetic patients with overt nephropathy (AMADEO Study)

    Study Document Trial synopsis 502.397_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.403
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase II
    Study Title

    A prospective, randomized, double-blind, placebo-controlled evaluation of the saftey, efficacy, and pharmacokinetics of MICARDIS (telmisartan) in children and adolescents with hypertension after four weeks of treatment

    Study Document Trial synopsis 502.403_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.445
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Efficacy and Safety of Micardis® in Treatment of Essential Hypertension

    Study Document Trial synopsis 502.445_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.450
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Pharmaco-epidemiological study describing the hypertensive population treated with Telmisartan and conditions of use by medical practitioners and patients

    Study Document Trial synopsis 502.450_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.486
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A phase IV study, prospective, randomised, open label, blinded endpoint, parallel group, 9 weeks of comparison between oral administration of telmisartan tablet (80 mg once daily) and amlodipine tablet (10 mg once daily) on biological PPAR ? activities in non controlled hypertensive male patients with metabolic syndrome

    Study Document Trial synopsis 502.486_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.493
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Efficacy and Safety of MICARDIS in Treatment of Mild to Moderate Essential Hypertension

    Study Document Trial synopsis 502.493_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.510
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study in everyday medical practice of the effectiveness of telmisartan for treatment of isolated systolic hypertension in comparison with systolic/diastolic hypertension in patients aged 55 or older

    Study Document Trial synopsis 502.510_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.513
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Morning hypertension and patient self-measurement

    Study Document Trial synopsis 502.513_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.519
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    An Observational Study to Evaluate the Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/day and 80 mg/day on the Mornings in Hypertensive Patients under the Real Condition of Usual Practice (Nice Mornings)

    Study Document Trial synopsis 502.519_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.521
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    TELMA A comparison of TELMisartan effectiveness in hypertensive patients with and without Albuminuria.

    Study Document Trial synopsis 502.521_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.523
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    TOP –study: Telmisartan – Therapy of hypertension and life-style changes in cardiovascular risk patients

    Study Document Trial synopsis 502.523_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.540
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    An Observational Post Marketing Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/day and 80 mg/day in Hypertensive Patients under real life conditions in usual clinical practice in the Kingdom of Saudi Arabia.

    Study Document Trial synopsis 502.540_DR english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.500
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Post-Marketing Surveillance of Micardis® (telmisartan) - Special drug use-results survey on long-term treatment

    Study Document Trial synopsis 502.500_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.254
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised,  double-blind, placebo-controlled, 6 week parallel-group trial on the efficacy and safety of the angiotensin II receptor antagonist Micardis® (telmisartan20 mg. 40 mg or 80 mg, p.o. once daily) or hydrochlorothiazide 12.5 mg p.o. once daily in the management of patients with isolated systolic hypertension (ISH). (ARAMIS­ study= Angiotensin II Receptor Antagonist Micardis in Isolated Systolic Hypertension)

    Study Document Trial synopsis 502.254 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.255
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    Natriuretic effect of Telmisartan Versus Placebo in Patients With Mild­ to-Moderate Hypertension On a Controlled Sodium Diet (100 mmol/day)

    Study Document Trial synopsis 502.255_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.256
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Prospective Randomized Open-Label Blinded End point (PROBE) Trial Comparing MICARDIS® (telmisartan) (80 mg QD) and Valsartan (80 mg QD) in Patients with Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring.

    Study Document Trial synopsis 502.256 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.257
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan (Micardis®) 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Lorzaar plus®, Hyzaar®) in Patients with Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring (OTELLOH-Study)

    Study Document Trial synopsis 502.257 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.258
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Prospective Randomized Open-Label Blinded-Endpoint (PROBE) Trial Comparing MICARDIS® (telmisartan) (80 mg QD) and Amlodipine (5 mg QD) in Patients with Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

    Study Document Trial synopsis 502.258 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.260
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIIb
    Study Title

    Open-Label Follow-up Trial on Efficacy and Safety of Chronic Administration of telmisartan 80 mg (Micardis®) Tablets as Monotherapy or in Combination with Hydrochlorothiazide or other Antihypertensive Medications in Patients with Mild to Moderate Hypertension

    Study Document Trial synopsis 502.260_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.266
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIb
    Study Title

    BIBR 277 Capsules Clinical Study on Hypertension with Nephropathy

    Study Document Trial synopsis 502.266_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.267
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, parallel-group comparison study of BIBR 277 capsule in patients with essential hypertension

    Study Document Trial synopsis 502.267_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.268
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IIa
    Study Title

    BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients

    Study Document Trial synopsis 502.268_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.314
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Safety, tolerability and efficacy of Micardis® (telmisartan) in patients with essential hypertension.

    Study Document Trial synopsis 502.314 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.317
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A PROBE (Prospective, Randomised, Open-Label, Blinded Endpoint) trial to investigate the efficacy and safety ofTelmisartan 40-80mg once daily compared with 10-20 mg enalapril once daily over a period of 24 weeks in elderly patients with blood hypertension.

    Study Document Trial synopsis 502.317 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.322
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Observation of Therapy with Micardis® (Telmisartan) in Patients with Essential Hypertension in Hospitals

    Study Document Trial synopsis 502.322 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.343
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective, Randomized, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (telmisartan) (40 & 80 mg QD) and COZAAR® (losartan) (50 & 100 mg QD) in Patients with Mild-to-Moderate Hypertension using Ambulatory Blood Pressure Monitoring.

    Study Document Trial synopsis 502.343 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.344
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective, Randomised, Double-Blind, Double-Dummy,Titration-to-Response Trial Comparing MICARDIS® (telmisartan) (40 or 80 mg p.o. once daily) and COZAAR® / LORZAAR® (losartan) (50 or 100 mg p.o. once daily) in Patients with Mild-to-Moderate Hypertension using Ambulatory Blood Pressure Monitoring.

    Study Document Trial synopsis 502.344 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.361
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® - Observational Study

    Study Document Trial synopsis 502.361 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.363
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A multicenter open-label study of the efficacy and safety of Telmisartan in mild to moderate hypertensive patients

    Study Document Trial synopsis 502.363_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.365
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    12 week, multi-center, randomized, double-blind, double dummy, parallel group trial comparing the efficacy and safety of 40 & 80 mg telmisartan and 50 & 100 mg Lorsatan in the treatment of 150 pairs of primary hypertension patients

    Study Document Trial synopsis 502.365 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.367
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label evaluation of trough and peak effects of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring inChinese patients with mild to moderate essential hypertension

    Study Document Trial synopsis 502.367 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.374
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Observation of Therapy with Micardis® (Telmisartan) in Patients with Essential Hypertension in Hospitals

    Study Document Trial synopsis 502.374 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.386
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Risk of morning hypertension

    Study Document Trial synopsis 502.386 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.479
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    The Post Marketing Surveillance Study conducted with a continuous enrollment method to assess serious adverse events, adverse events, safety, efficacy of Micardis Tablet (telmisartan 20, 40, 80mg p.o. once daily)

    Study Document Trial synopsis 502.479_CO english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.461
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    An Open-label Evaluation of the Effectiveness of MICARDIS® (telmisartan) on Blood Pressure Control and Qualify of Life in Patients with Essential Hypertension

    Study Document Trial synopsis 502.461 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.599
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    The use of angiotensin receptor blockers and the risk of cancer

    Study Document Trial synopsis 502.599 english
  • MICARDIS ® - Hypertension
    Clinical Study Number 502.590
    Study Indication Hypertension
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    ANTIHYPERTENSIVE MEDICATIONS AND THE RISK OF SEPSIS

    Study Document Trial synopsis 502.590 english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.585
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascula (CV) Risk Factor Index in High Risk hypertensive Patients

    Study Document Trial synopsis 502.585_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.581
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    RESPECT: Observational, prospective, open-label, multi-center study evaluating the antihypertensive effect of treatment with telmisartan (alone or in fixed combination with HCTZ) in general practitioner and specialist practice in hypertensive patients with high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 who are uncontrolled under current treatment

    Study Document Trial synopsis 502.581 english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.316
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) trial to investigate the efficacy and safety of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily over a period of 12 weeks, and of telmisartan 80 mg + HCTZ 12.5 mg once daily compared with losartan 100 mg once daily + HCTZ 12.5 mg once daily over a period of further 12 weeks in mild to moderate hypertensive patients (grade 1 and grade 2 WHO-ISH guidelines 1999)

    Study Document Trial synopsis 502.316_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.399
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    SMOOTH - A prospective, randomised, open-label, blinded endpoint, forced-titration trial to compare MICARDIS® PLUS / MICARDIS® HCT (telmisartan combined with hydrochlorothiazide 80 mg/12.5 mg) to DIOVAN HCT® (valsartan combined with hydrochlorothiazide 160 mg/12.5 mg), for the control of mild-to-moderate hypertension in obese patients with Type 2 diabetes mellitus using ambulatory blood pressure monitoring

    Study Document Trial synopsis 502.399_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.421
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, double-dummy, placebo-controlled, forced-titration, comparison of MICARDIS® HCT (telmisartan 80 mg/hydrochlorothiazide 25 mg) versus DIOVAN® HCT (valsartan 160 mg / hydrochlorothiazide 25 mg) using seated trough cuff blood pressure in patientswith Stage 1 and Stage 2 hypertension.

    Study Document Trial synopsis 502.421_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.427
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing Surveillance Study MicardisPlus®

    Study Document Trial synopsis 502.427_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.428
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance Study in Rehabilitation Clinics (cardio, nephro, diabetes, pulmo)

    Study Document Trial synopsis 502.428_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.429
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan +Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance Study in Rehabilitation Clinics (cardio, nephro, diabetes, pulmo)

    Study Document Trial synopsis 502.429_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.430
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance Study in Rehabilitation Clinics (cardio, nephro, diabetes, pulmo)

    Study Document Trial synopsis 502.430_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.431
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance Study in Rehabilitation Clinics (cardio, nephro, diabetes, pulmo)

    Study Document Trial synopsis 502.431_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.436
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    A Randomised, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg (Micardis®) in Patients Who Fail to Respond Adequately to Treatment with Telmisartan (Micardis®) 40 mg.

    Study Document Trial synopsis 502.436_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.439
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomised, Double-Blind, Placebo-Controlled, 3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension.

    Study Document Trial synopsis 502.439_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.441
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® / MicardisPlus® PROTEKT - (Program for therapy optimization with telmisartan in cardiovascular diseases)

    Study Document Trial synopsis 502.441_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.442
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® / MicardisPlus® PROTEKT - (Program for therapy optimization with telmisartan in cardiovascular diseases)

    Study Document Trial synopsis 502.442_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.443
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® / MicardisPlus® PROTEKT - (Program for therapy optimization with telmisartan in cardiovascular diseases)

    Study Document Trial synopsis 502.443_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.467
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Observational Study for Event Monitoring: Micardis ® (Telmisartan) / Micardis Plus ® (Telmisartan + Hydrochlorothiazide)

    Study Document Trial synopsis 502.467_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.472
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Eight Week Randomized, Double-Blind, Double-dummy Study Comparing a Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlothiazide 12.5mg to Telmisartan 80mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80mg

    Study Document Trial synopsis 502.472_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.485
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Morning hypertension and monitoring of metabolism (AWB Morgenhochdruck & Stoffwechselmonitoring)

    Study Document Trial synopsis 502.485_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.487
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A post marketing observational study to investigate the efficacy, safety,tolerability and the effect on quality of life of Telmisartan (Micardis®) and Telmisartan with HCTZ (Micardis Plus®) in patients with hypertension

    Study Document Trial synopsis 502.487_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.490
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Reduction of microalbuminuria with Micardis® (MicMic)

    Study Document Trial synopsis 502.490_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.494
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Observational Study about the use of Telmisartan in Hypertensive Patients

    Study Document Trial synopsis 502.494_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.532
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical EvaluatioN of TElmisartan-based antihypertensive Regimen (CENTER)

    Study Document Trial synopsis 502.532_DR english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.505
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

    Study Document Trial Synopsis 502.505_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.506
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

    Study Document Trial synopsis 502.506_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.261
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg.

    Study Document Trial synopsis 502.261 english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.323
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination ofTelmisartan 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg. 

    Study Document Trial synopsis 502.323 english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.496
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A study of a hypertensive population under treatment with Micardis® and Micardis Plus® under real clinical conditions with the goal to control the early morning BP rise (SURGE II)

    Study Document Trial synopsis 502.496 english
  • MICARDIS ® , MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.602
    Study Indication Hypertension
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Treatment adherence to JNC 7 guidelines in cardiovascular (CV)-risk patients across the Middle East- the impact of Ramadan fasting on achieving treatment goals in daily practice

    Study Document Trial synopsis 502.602_DR english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.387
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined with Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets with Losartan Combined with Hydrochlorothiazide (50 mg/12.5 mg) Tablets using Ambulatory Blood Pressure Monitoring in Patients with Mild-to-Moderate Hypertension

    Study Document Trial synopsis 502.387_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.390
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance Study Micardis plus

    Study Document Trial synopsis 502.390_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.400
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A comparison of telmisartan 80 mg + hydrochlorothiazide 12.5 mg with amlodipine 10 mg + hydrochlorothiazide 12.5 mg in the control of blood pressure in older patients with predominantly systolic hypertension. A prospective, randomised, open-label, blinded end-point evaluation. (ATHOS study)

    Study Document Trial synopsis 502.400_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.406
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg + HCTZ 12.5 mg in Comparison with Losartan 50mg + HCTZ 12.5 mg in Taiwanese Patients with Mild to Moderate Hypertension

    Study Document Trial synopsis 502.406_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.476
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, forced-titration, Phase IV study comparing telmisartan 80 mg + hydrochlorothiazide 25 mg versus valsartan 160 mg + hydrochlorothiazide 25 mg taken orally for eight weeks in patients with Stage 1 and Stage 2 hypertension.

    Study Document Trial synopsis 502.476_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.480
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    A prospective randomised study to compare a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in patients with uncontrolled hypertension who fail to respond adequately to treatment with afixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg

    Study Document Trial synopsis 502.480_DR english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.488
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open-label study to evaluate the trough and peak effect of once daily MicardisPlus® (Telmisartan 80mg / hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension

    Study Document Trial synopsis 502.488_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.491
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An open-label follow-up trial of the efficacy and safety of chronic administration of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension

    Study Document Trial synopsis 502.491 english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.516
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation

    Study Document Trial synopsis 502.516_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.550
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, double dummy, active controlled, parallel group, forced titration study to compare the fixed-dose combination of Telmisartan 80mg plus Hydrochlorothiazide 25mg (T80/HCTZ25) versus Telmisartan 80mg (T80) monotherapy as first line therapy in patients with grade 2 or grade 3 hypertension (SBP ?160 mmHg and DBP ?100 mmHg)

    Study Document Trial synopsis 502.550_DR english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.574
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    A descriptive pharmaco-epidemiological study of a hypertensive patient population treated with a fixed-dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg and of conditions for the management of arterial hypertension

    Study Document Trial synopsis 502.574_DR english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.508
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Pharmaco-epidemiological study describing a population of hypertensive patients treated in general practice with a fixed-dose combination of Telmisartan and hydrochlorothiazide, the level of blood pressure control and the modalities of arterial hypertension [AHT] management

    Study Document Trial synopsis 502.508_CO english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.542
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance on Long-Term Drug Use of Micombi® Combination Tablets in Patients with Hypertension

    Study Document Trial synopsis 502.542_DR english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.321
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Open-Label, Six Month Safety Evaluation of the Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Mild-to-Moderate Hypertension

    Study Document Trial synopsis 502.321 english
  • MICARDIS PLUS ® - Hypertension
    Clinical Study Number 502.475
    Study Indication Hypertension
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance to assess the safety and efficacy of Micardis® Plus tablet (fixed dose combination of telmisartan and hydrochlorothiazide, q.d.) of 40/12.5mg or 80/12.5mg taken orally for more than 2 weeks in Korean patients with essential hypertension (KFDA regulatory requirement PMS)

    Study Document Trial synopsis 502.475_DR english
  • MICATRIO ® - Hypertension
    Clinical Study Number 1348.2
    Study Indication Hypertension
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg and amlodipine 5 mg and hydrochlorothiazide 12.5 mg vs. telmisartan 80 mg and hydrochlorothiazide 12.5 mg in patients with hypertension who fail to respond adequately to treatment with telmisartan 80 mg and hydrochlorothiazide 12.5 mg, followed by a 52-week extension study to assess long-term safety of telmisartan 80 mg andamlodipine 5 mg and hydrochlorothiazide 12.5 mg

    Study Document Trial synopsis 1348.2_DR english
  • MICATRIO ® - Hypertension
    Clinical Study Number 1348.1
    Study Indication Hypertension
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg and amlodipine 5 mg and hydrochlorothiazide12.5 mg vs. telmisartan 80 mg and amlodipine 5 mg in patients with hypertension who fail to respond adequately to treatment with telmisartan 80 mg and amlodipine 5 mg

    Study Document Trial synopsis 1348.1_DR english
  • MOTENS ® - Hypertension
    Clinical Study Number 231.215
    Study Indication Hypertension
    Product MOTENS ®
    Generic Name Lacidipine
    Lab Code
    Clinical Phase III
    Study Title

    Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions during Long-term Therapy. 1st, 2nd and 3rd Follow-up Study - Long-term Use in the 2nd, 3rd, 4th and 5th Treatment Year.

    Study Document Trial synopsis 231.215 english
  • MOTENS ® - Hypertension
    Clinical Study Number 231.336
    Study Indication Hypertension
    Product MOTENS ®
    Generic Name Lacidipine
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, parallel-group, double-blind, double-dummy study to compare the effects of lacidipine versus bendrofluazide on markers of platelet activation and haemorheological factors in hypertensive patients.

    Study Document Trial synopsis 231.336_CO english
  • MOTENS ® - Hypertension
    Clinical Study Number 231.340
    Study Indication Hypertension
    Product MOTENS ®
    Generic Name Lacidipine
    Lab Code
    Clinical Phase IV
    Study Title

    Observation of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension, under normal conditions compared with an open clinical trial.

    Study Document Trial synopsis 231.340 english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.41
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets versus Micardis 80 mg Tablets with Norvasc 10 mg Tablets under Fasting Conditions

    Study Document Trial synopsis 1235.41 english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.5
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised, 4-arm, double-blind study to compare the efficacy and safety of combinations of telmisartan 40 mg + amlodipine 5 mg versus telmisartan 80 mg + amlodipine 5 mg versus amlodipine 5 mg monotherapy versus amlodipine 10 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 5 mg monotherapy.Telmisartan plus Amlodipine Study in Amlodipine 5 mg Non-Responders in Hypertension: TEAMSTA-5

    Study Document Trial synopsis 1235.5_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.1
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, double-dummy placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABPM sub-study

    Study Document Trial synopsis 1235.1_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.21
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over-encapsulated tablets as first line therapy in patients with Type 2 Diabetes Mellitus and Stage 1 or 2 hypertension: a Phase III, eight week, randomised, double-blind, double-dummy, forced titration comparison with an ABPM sub-study

    Study Document Trial synopsis 1235.21_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.6
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised, 3-arm, double-blind study to compare the safety and efficacy of the combination of telmisartan 40 mg + amlodipine 10 mg versus telmisartan 80 mg + amlodipine 10 mg versus amlodipine 10 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 10 mg monotherapy.Telmisartan plus Amlodipine Study in Amlodipine 10 mg Non-Responders in Hypertension: TEAMSTA-10

    Study Document Trial synopsis 1235.6_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.7
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40 mg + amlodipine 5 mg or the combination of telmisartan 80 mg + amlodipine 5 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension

    Study Document Trial synopsis 1235.7_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.8
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40 mg + amlodipine 10 mg or the combination of telmisartan 80 mg + amlodipine 10 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension

    Study Document Trial synopsis 1235.8_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.13
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind trial to compare telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination to amlodipine 5 mg monotherapy in patients not controlled with amlodipine 5 mg monotherapy

    Study Document Trial synopsis 1235.13_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.14
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind trial to compare telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination to telmisartan 40 mg monotherapy in patients not controlled with telmisartan 40 mg monotherapy

    Study Document Trial synopsis 1235.14_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.16
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label, long-term study of telmisartan plus amlodipine fixed-dose combination (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) to evaluate 1-year long-term safety and efficacy in the patients with essential hypertension

    Study Document Trial synopsis 1235.16_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.20
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tabletSTudy versus Amlodipine 10 mg over encapsulated tablets or telmisartan 80 mg tablets as first line therapy in patients with severe HyperTensioN: A Phase III 8-week, randomised, double-blind, double-dummy, forced-titration comparison (TEAMSTA severe HTN)

    Study Document Trial synopsis 1235.20_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.33
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIb
    Study Title

    Prospective, open label TElmisartan/AMlodipine single pill STudy to Assess the efficacy in patients with essential hypertension who are not controlled on RAASi mono-therapy being switched TEAMSTA switch

    Study Document Trial synopsis 1235.33_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.36
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and   safety of telmisartan 80 mg + amlodipine 5 mg fixed-dose combination vs.   telmisartan 80 mg monotherapy in patients with hypertension who fail to   respond adequately to treatment with telmisartan 80 mg monotherapy

    Study Document Trial synopsis 1235.36_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.31
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label study to evaluate the antihypertensive effects of the fixed-dose combination of telmisartan 80 mg and amlodipine 5 mg (T80/A5) given once daily by 24-h ABPM in patients with moderate to severe hypertension

    Study Document Trial synopsis 1235.31_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.29
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

    An eight-week randomized, double-blind, multicentre study to evaluate the efficacy and safety of fixed-dose combinations of telmisartan 80 mg plus amlodipine 5 mg versus amlodipine 5 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 5 mg monotherapy

    Study Document Trial synopsis 1235.29_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.37
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg plus amlodipine 5 mg fixed-dose combination vs. telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination in patients with hypertension

    Study Document Trial synopsis 1235.37_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.38
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IV
    Study Title

    Survey on Drug Use of Micamlo® Combination Tablets AP in Patients with Hypertension

    Study Document Trial synopsis 1235.38_DR english
  • Telmisartan + Simvastatin - Hypertension
    Clinical Study Number 1228.1
    Study Indication Hypertension
    Product Telmisartan + Simvastatin
    Generic Name Telmisartan + Simvastatin
    Lab Code
    Clinical Phase II
    Study Title

    Reduced factorial design, randomized, double-blind trial comparing combinations of telmisartan 20 or 80 mg and simvastatin 20 or 40 mg with single component therapies in the treatment of hypertension and dyslipidemia

    Study Document Trial synopsis 1228.1_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.40
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IV
    Study Title

    A Regulatory Requirement Post-Marketing Surveillance Study to monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy

    Study Document Trial synopsis 1235.40_PR english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.