Isolated Systolic Hypertension in the Elderly and Very Elderly

Phase 3

Completed

• Conditions: Isolated Systolic Hypertension
• Interventions: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary; Drug: nitrendipine + hydrochlorothiazide, if necessary

• Registration Number: NCT00751829
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2004-10
• Study Completion: 2005-02
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olmesartan medoxomil + hydrochlorothiazide, if necessary	oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP
2	nitrendipine + hydrochlorothiazide, if necessary	oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP	after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment
Change in mean sitting systolic blood pressure assessed by conventional BP measurements	After 1, 2, 4, 8, 12, 16, 20, and 24 weeks