Official Title: “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”

Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Irbesartan
• Drug: ramipril

Primary Measures

• Change in AER from baseline to Week 20

Secondary Measures

• Change from baseline in seated systolic and diastolic blood pressures at Week 20; Comparison of change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups

Inclusion Criteria:

• Subjects must be willing and able to provide written informed consent.
• Males and Females 55 years of age and over
• Subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following:
• 1. Diabetes
• 2. Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia
• 3. Artery disease in the legs, limiting walking capacity and/or blood flow in the legs
• 4. Stroke occurring more than 3 months prior to the screening visit
• All subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit.
• All subjects must currently be treated with a class of drugs called ACE inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study.
• Women of childbearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Acute systemic febrile/infectious disease or infectious or inflammatory disease of the kidneys
• Narrowing of the kidney arteries
• Hypotension (low blood pressure) or very high blood pressure
• Moderate or Severe Heart Failure
• Chronic autoimmune disease
• Cancer unless cured or no further treatment needed
• Severe kidney failure
• Allergy to drugs used in the study: ARBs (candesartan, irbesartan, losartan, telmisartan, valsartan, and/or any other ARB currently or previously in development) and ACE-inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril)
• Administration of any other investigational drug within 30 days of planned enrollment into the study.
• Any circumstances that would prevent coming for study visits or taking study drugs

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095290

Study ID Number: CV131-169

ClinicalTrials.gov Identifier: NCT00095290

Health Authority: United States: Food and Drug Administration

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