Value through Innovation27 July 2016

Clinical Study Results

  • 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 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
  • 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 ® - Healthy
    Clinical Study Number 502.415
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan and HCTZ p.o. (80 mg telmisartan/12.5 mg HCTZ) in two experimental formulations (givent.i.d. for one day each) compared to the standard formulation 80 mg telmisartan/12.5 mg HCTZ (MicardisPlus®), given t.i.d. for one day in healthy female and male subjects. A three-way crossover, open,randomised study.

    Study Document Trial synopsis 502.415 english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.437
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 40 mg telmisartan / 12.5 mg HCTZ of fixed dose combination compared to its monocomponents in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 502.437_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.438
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 80 mg telmisartan/12.5 mg HCTZ of fixed dose combination compared to its monocomponents in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 502.438_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.453
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and multiple oral doses (80 mg Telmisartan / 12.5 mg HCTZ) of drug in healthy male volunteers

    Study Document Trial synopsis 502.453_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.495
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dosecombination compared with its monocomponents in healthy malevolunteers II (an open-label, randomised, single-dose, two-sequence,four-period replicated crossover study)

    Study Document Trial synopsis 502.495_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.571
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan administrated in two different ways: either in telmisartan 80 mg/HCTZ 12.5 mg fixed-dose combination tablet or as two telmisartan 40 mg tablets (an open-label, randomised, single-dose, four-periodreplicated crossover study)

    Study Document Trial synopsis 502.571_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.569
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Influence of food on the bioavailability of telmisartan 40 mg/HCTZ 12.5 mgfixed-dose combination and of telmisartan 80 mg/HCTZ 12.5 mg fixed-dosecombination in Japanese healthy male volunteers (an open-label, randomised,single-dose, two-way crossover study)

    Study Document Trial synopsis 502.569_CO 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

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