A Randomised, Double- Blind, Placebo-controlled, 6 Week Parallel-group Trial on the Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan 20 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)

NCT02175355 Phase 3 COMPLETED

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.

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	COMPLETED
Enrolment	1039
Start date	1999-10

Conditions

• Hypertension

Interventions

• Low dose of Micardis®
• Medium dose of Micardis®
• High dose of Micardis®
• Hydrochlorothiazide
• Placebo

Primary outcomes

• Change from baseline in seated systolic blood pressure at trough (24 hours post-dose) — after 6 weeks of treatment
• Change from baseline in urine albumine excretion rate — after 6 weeks of treatment
• Change from baseline in pulse wave velocity — after 6 weeks of treatment