Irbesartan versus Placebo in Combination with Standard Cardiovascular Protection ACE-I Therapy with Ramipril for the Treatment of Hypertensive Albuminuria in Subjects at Elevated Cardiovascular Risk - IMPROVE

• Conditions: Albuminuria in hypertensive subjects at increased cardiovascular risk

• Registration Number: EUCTR2004-000022-75-LV
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

males and females 55 years of age and over
documented histroy of hypertension
subjects with demonstrated albuminuria as measured using a urine dipstick
subjects with one or more additional cardiovascular risk factors defined as: diabetes, advanced coronary artery disease defined as previous myocardial infarction, unstable angina, or angina pectoris with a positive stress test or at least two-vessel disease demonstarted on a coronary angiogram; peripheral vascular disease- angiographically proven or prior vascular surgery, amputation or intermittent claudication with a ankle/ brachial pressure index of < 0.9; cerebrovascular accident occurring greater tham 3 months prior to the screening visit; subjects currently on a stable dose of a ACE-I therapy equivalent to 5mg or more of ramipril for a minimum of 2 months prior to their screening/ enrollment visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the change in albumin excretion rate (AER) measured in overnight urine collections from baseline to week 20 between groups assigned to ramipril and irbesartan or to ramipril and placebo in hypertensive subjects with increased cardiovascular risk.;Secondary Objective: To estimate the reduction from baseline in seated systolic and diastolic blood pressures at week 20 within each of the treatment groups.<br>To compare the change from baseline in seated systolic and diastolic blood pressures at week 20 between treatment groups<br>To charaterise the safety profiles of each of the two treatment groups.;Primary end point(s): The primaru efficacy outcome measure will be defined as the change in AER from baseline to week 20, Secondary efficacy measures will be change from baseline in seated systolic and diastolic blood pressures at week 20