Status:
COMPLETED
Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Sanofi
Conditions:
Albuminuria
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00095290
Start Date
September 1 2004
End Date
November 1 2005
Last Update
April 15 2011
Active Locations (92)
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1
Local Institution
Tustin, California, United States
2
Local Institution
Miami, Florida, United States
3
Local Institution
West Palm Beach, Florida, United States
4
Local Institution
Chicago, Illinois, United States