Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

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

Details

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

Criteria

Inclusion Criteria:

• Age 65 years or older

• Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG

Exclusion Criteria:

• Secondary hypertension

• Malignant hypertension

• Severe heart failure (NYHA III-IV)

• History or evidence of renal disease

• Recent history of myocardial infarction

• Hypersensitivity to study drugs

• History of drug or alcohol abuse