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 ® - Cardiovascular Diseases
    Clinical Study Number 502.373
    Study Indication Cardiovascular Diseases
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase III
    Study Title

    1.ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET). A large, simple, randomised, double-blind, multicentre, international trial comparing the effects of telmisartan, ramipril and their combination on outcomes in patients at high risk for cardiovascular events. 2. Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease (TRANSCEND). A large, simple, randomized, double-blind, multicentre, international trial comparing the effects of telmisartan with placebo on outcomes in patients at high risk for cardiovascular events and intolerant of ACE-I

    Study Document Trial synopsis 502.373 Ontarget_CO english Trial synopsis 502.373 Transcend_CO 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 ® - Diabetic Nephropathies
    Clinical Study Number 502.396
    Study Indication Diabetic Nephropathies
    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 investigate the efficacy of Telmisartan 80 mg versus Valsartan 160 mg in hypertensive type 2 diabetic patients with overt nephropathy - VIVALDI-Study

    Study Document Trial synopsis 502.396_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 ® - Diabetes Mellitus, Type 2
    Clinical Study Number 502.398
    Study Indication Diabetes Mellitus, Type 2
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, randomized, double-blind, double-dummy, forced titration, parallel group comparison, multicenter trial to compare the effects of either telmisartan (40-80 mg p.o. once daily) or ramipril (5-10 mg p.o. once daily) on renal endothelial dysfunction in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks

    Study Document Trial synopsis 502.398_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 ® - Diabetic Nephropathies
    Clinical Study Number 502.413
    Study Indication Diabetic Nephropathies
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, multicenter trial to investigate the preventive effect of BIBR277 (telmisartan) in diabetic nephropathy on transition from incipient to overt nephropathy. - Incipient to overt: angiotensin 2 receptor blocker, telmisartan, investigation on type 2 diabetic nephropathy (INNOVATION Study)

    Study Document Trial synopsis 502.413_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 ® - Obesity, Insulin Resistance
    Clinical Study Number 502.469
    Study Indication Obesity, Insulin Resistance
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group, 16-week MICARDIS® (160 mg) tablets, proof-of-concept study, evaluating insulin sensitivity in overweight or obese, non-diabetic, normotensives, using the oral glucose tolerance test, with a clamp sub-group

    Study Document Trial synopsis 502.469_DR 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 ® - Healthy
    Clinical Study Number 502.136
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination compared with its monocomponents in healthy subjects. A 4 period cross-over, randomized, replicate design study.

    Study Document Trial synopsis 502.136 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 ® - Healthy
    Clinical Study Number 502.341
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of single oral doses of 40 mg simvastatin and its metabolite simvastatin acid with and without concomitant administration of telmisartan 80 mg daily, given orally over 6 days. A randomised, placebo controlled, double blind (for telmisartan), two way cross over trial in healthy subjects

    Study Document Trial synopsis 502.341_CO 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 ® - Healthy
    Clinical Study Number 502.378
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo controlled, 6 parallel groups study to assess the influence of telmisartan (40 mg or 160 mg), lacidipine (4 mg or 6 mg) and their combination (telmisartan 40 mg and lacidipine 4 mg) p.o. once daily for seven days on the QT interval of the ECG in healthy male and female volunteers

    Study Document Trial synopsis 502.378_CO 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 ® - Healthy
    Clinical Study Number 502.402
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Does telmisartan compared to candesartan due to a distinctly larger volume of distribution exert stronger effects in relevant peripheral tissues, e.g. renal and adrenal tissues 

    Study Document Trial synopsis 502.402_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.414
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of BIBR 277 tablet (Erythritol based) compared with its capsule formulation in healthy male volunteers.

    Study Document Trial synopsis 502.414_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.417
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of BIBR 277 tablet (Mannitol based) compared with its capsule formulation in healthy male volunteers

    Study Document Trial synopsis 502.417_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.457
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan and SR26334, the main metabolite of clopidogrel, after co-administration compared to the bioavailability of telmisartan and SR26334 after p.o. administration of 80 mg telmisartan and 75 mg clopidogrel alone. A four-way, single dose, open, randomised crossover study in 24 healthy male and female subjects

    Study Document Trial synopsis 502.457_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.458
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan in Micardis® and of dipyridamole in Aggrenox®  after co-administration compared to the bioavailability of telmisartan respectively of dipyridamole after oraladministration of 80 mg telmisartan respectively of 25 mg ASA/200 mg extended-release dipyridamole alone. An open-label,randomised, single-dose, four-way crossover study in 24 healthy female and male subjects

    Study Document Trial synopsis 502.458_CO 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 ® - Healthy
    Clinical Study Number 502.557
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of the telmisartan 80 mg film-coated tablet compared with two tablets of the telmisartan 40 mg conventional tablet following oral administration in healthy male volunteers (an open-label, randomised, single dose,two-sequence, four-period replicated crossover study)

    Study Document Trial synopsis 502.557_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.520
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of the 40 mg telmisartan film-coated tablet compared with the conventional 40 mg telmisartan tablet following oral administration in healthy male volunteers (an open-label, randomised, single-dose, two-sequence, four period replicated crossover study)

    Study Document Trial synopsis 502.520_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 ® - 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 PLUS ® - Healthy
    Clinical Study Number 502.324
    Study Indication Healthy
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of 40 mg Telmisartan I 12.5 mg HCTZ fixed dose combination compared with its monocomponents in healthy subjects. A 4 period cross-over, open, randomized, replicate design study.

    Study Document Trial synoposis 502.324 english
  • 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 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

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