Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Albuminuria

Treatments

Drug: Ramipril + Placebo

Drug: Ramipril + Irbesartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095290

CV131-169

Details and patient eligibility

About

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.

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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