Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

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:

• Diabetes
• Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia
• Artery disease in the legs, limiting walking capacity and/or blood flow in the legs
• 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