Isolated Systolic Hypertension in the Elderly and Very Elderly

NCT ID: NCT00751829

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-02-28

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.

Conditions

Isolated Systolic Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: EXPERIMENTAL

olmesartan medoxomil + hydrochlorothiazide, if necessary

Intervention Type: DRUG

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 control BP

2

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

Group Type: ACTIVE_COMPARATOR

nitrendipine + hydrochlorothiazide, if necessary

Intervention Type: DRUG

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

Interventions

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 control BP

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Daiichi Sankyo Europe, GmbH

Principal Investigators

Peter U Witte, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

IMFORM GmbH

Locations

Munich, , Germany

Countries

Germany

Other Identifiers

SE-866/37

Identifier Type: -

Identifier Source: org_study_id