Isolated Systolic Hypertension in the Elderly and Very Elderly

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Treatments: Hydrochlorothiazide; Nitrendipine; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• Age 65 or older

• Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg

Exclusion Criteria:

• Secondary hypertension

• Malignant hypertension

• Severe Heart Failure (NYHA III-IV)

• Recent history of myocardial infarction

• Hypersensitivity to study medications

• History of drug or alcohol abuse

• History or evidence of renal disease