drugset / Trial / NCT02175355

Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)

NCT02175355

Phase 3 Completed 1039 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg. Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations, heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity of adverse events.

Timeline

Start
1999-10
Primary completion
2000-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 12.5 mg Oral
Subject Telmisartan Other / unclassified 20 mg Oral
Subject Telmisartan Other / unclassified 40 mg Oral
Subject Telmisartan Other / unclassified 80 mg Oral

Indications