Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: losartan + hydrochlorothiazide, if necessary; Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

• Registration Number: NCT00751751
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-04
• Study Completion: 2005-06
• Status Verified: 2008-09
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Last Update Submitted: 2008-09-11
• Study First Posted: 2008-09-12
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	losartan + hydrochlorothiazide, if necessary	oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.
1	olmesartan medoxomil + hydrochlorothiazide, if necessary	oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic BP assessed by conventional BP measurements	after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP	after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks