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

Active, not recruiting

• Conditions: Albuminuria in hypertensive subjects at increased cardiovascular risk.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

1) Males and Females 55 years of age and over.
2) Documented history of Hypertension
3) Subjects with demonstrated albuminuria as measured using a urine dipstick.
4) Subjects with one or more additional cardiovascular risk factors defined as:
a) Diabetes
b) Advanced coronary artery disease (CAD) defined as previous myocardial
infarction (MI), unstable angina, or angina pectoris with a positive stress test or at
least two-vessel disease demonstrated on a coronary angiogram.
c) Peripheral vascular disease (PVD) - angiographically proven or prior vascular
surgery, amputation or intermittent claudication with an ankle/brachial pressure
index of < 0.9.
d) Cerebrovascular accident (CVA) occurring greater than 3 months prior to the
screening visit
5) Subjects currently on a stable dose of ACE-I therapy equivalent to 5 mg 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

1) Febrile disease, urinary infection, documented uncontrolled diabetes (HbA1c = 10%), acute glomerulonephritis, excessive exercise or other condition affecting proteinuria.
2) Renovascular disease
3) Systolic blood pressure = 115 mm Hg and or = 200mm Hg and or, a diastolic
BP = 115 mm Hg.
4) Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) Class III and IV (see Appendix 2)
5) Renal Insufficiency defined as - creatinine level of = 2.5 mg/dL
6) Hyperkalemia - serum potassium > 5.5 mmol/L
7) Chronic steroid or non-steroidal anti-inflammatory (NSAID) use. Aspirin is
permitted.
8) Immunosuppressant medication use is prohibited during the study.

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<br>collections from baseline to Week 20 between groups assigned to ramipril and irbesartan or to ramipril and placebo in hypertensive subjects with increased cardiovascular (CV) risk.;Secondary Objective: 1) To estimate the reduction from baseline in seated systolic and diastolic blood pressures at Week 20 within each of the treatment groups.<br>2) To compare the change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups.<br>3) To characterize the saftey profiles of each of the two treatment groups.;Primary end point(s): The primary efficacy outcome measure will be defined as the change in AER<br>from baseline to Week 20. Secondary efficacy measures will be the change from baseline in seated systolic and diastolic blood pressures at Week 20.