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 riskdefined as one of the following:

1. Diabetes

2. Advanced coronary disease defined as previous myocardial infarction. Activeangina, or significant changes in tests indicating ischemia

3. Artery disease in the legs, limiting walking capacity and/or blood flow in thelegs

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 aurine 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 ofcontraception to avoid pregnancy throughout the study and four weeks after the studyends.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.

• Acute systemic febrile/infectious disease or infectious or inflammatory disease of thekidneys

• 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 enrollmentinto the study.

• Any circumstances that would prevent coming for study visits or taking study drugs