Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
NCT ID: NCT00095290
Last Updated: 2011-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2004-09-30
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
A2
Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Interventions
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Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Locations
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Local Institution
Tustin, California, United States
Local Institution
Miami, Florida, United States
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West Palm Beach, Florida, United States
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Chicago, Illinois, United States
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Flushing, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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San Antonio, Texas, United States
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Milwaukee, Wisconsin, United States
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Burwood, New South Wales, Australia
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Camperdown, New South Wales, Australia
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Gosford, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Parkville, Victoria, Australia
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Fremantle, Western Australia, Australia
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Boulogne-sur-Mer, , France
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Colmar, , France
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Grenoble, , France
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Pessac, , France
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Strasbourg, , France
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Aschaffenburg, , Germany
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Bad Mergentheim, , Germany
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Göttingen, , Germany
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Halle, , Germany
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Künzing, , Germany
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München, , Germany
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Ornbau, , Germany
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Vellmar, , Germany
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Villingen-Schwenningen, , Germany
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Ashkelon, , Israel
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Beersheba, , Israel
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Hadera, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Kiryat Biyalik, , Israel
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Nazareth, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Chieri, , Italy
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Genova, , Italy
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Lecco, , Italy
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Napoli, , Italy
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Rimini, , Italy
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Rome, , Italy
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San Benedetto del Tronto, , Italy
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Daugavpils, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Panevezys, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Monterrey, Nuevo León, Mexico
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México, San Lis Potosi, Mexico
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Amsterdam, , Netherlands
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Blaricum, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Stadskanaal, , Netherlands
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Zeist, , Netherlands
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Zwolle, , Netherlands
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Moscow, , Russia
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Saint Petersburg, , Russia
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Barcelona, , Spain
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Jerez de la Frontera, , Spain
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Las Palmas de G. C., , Spain
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Madrid, , Spain
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Marbella, , Spain
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Middlesbrough, Cleveland, United Kingdom
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Belfast, County Durham, United Kingdom
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Birmingham, West Midlands, United Kingdom
Local Institution
Derby, West Midlands, United Kingdom
Countries
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References
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Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.
Other Identifiers
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CV131-169
Identifier Type: -
Identifier Source: org_study_id
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