Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
Albuminuria
About this trial
This is an interventional treatment trial for Albuminuria focused on measuring Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
A1
A2