drugset
drugset / Trial / NCT00751829

Isolated Systolic Hypertension in the Elderly and Very Elderly

NCT00751829 ↗

Phase 3 Completed 417 enrolled Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.

Timeline

Start
2003-07
Primary completion
2004-10
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitrendipine Small molecule 10 mg Oral
Comparator Nitrendipine Small molecule 20 mg Oral
Subject Olmesartan medoxomil Unknown 20 mg Oral
Subject Olmesartan medoxomil Unknown 40 mg Oral
Background Hydrochlorothiazide Unknown 12.5 mg Oral
Background Hydrochlorothiazide Unknown 25 mg Oral

Indications

No indication recorded.