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 treatment regimen that consists of irbesartan taken at the same time with
ramipril.
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:
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:
- 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
Local Institution, Boulogne Sur Mer, France
Local Institution, Colmar, France
Local Institution, Grenoble Cedex 9, France
Local Institution, Pessac, France
Local Institution, Strasbourg, France
Local Institution, Aschaffenburg, Germany
Local Institution, Bad Mergentheim, Germany
Local Institution, Gottingen, Germany
Local Institution, Halle, Germany
Local Institution, Kunzing, Germany
Local Institution, Munchen, Germany
Local Institution, Ornbau, Germany
Local Institution, Vellmar, Germany
Local Institution, Villingen-Schwenningen, Germany
Local Institution, Ashkelon, Israel
Local Institution, Beer Sheva, Israel
Local Institution, Hadera, Israel
Local Institution, Holon, Israel
Local Institution, Jerusalem, Israel
Local Institution, Kfar Saba, Israel
Local Institution, Kiryat Biyalik, Israel
Local Institution, Nazaret, Israel
Local Institution, Ramat-Gan, Israel
Local Institution, Rehovot, Israel
Local Institution, Tel Aviv, Israel
Local Institution, Zerifin, Israel
Local Institution, Chieri, Italy
Local Institution, Genova, Italy
Local Institution, Lecco, Italy
Local Institution, Napoli, Italy
Local Institution, Rimini, Italy
Local Institution, Rome, Italy
Local Institution, San Benedetto del Tronto, Italy
Local Institution, Daugavpils, Latvia
Local Institution, Riga, Latvia
Local Institution, Kaunas, Lithuania
Local Institution, Klaipeda, Lithuania
Local Institution, Panevezys, Lithuania
Local Institution, Siauliai, Lithuania
Local Institution, Vilnius, Lithuania
Local Institution, Aguascalientes, Mexico
Local Institution, Amsterdam, Netherlands
Local Institution, Blaricum, Netherlands
Local Institution, Eindhoven, Netherlands
Local Institution, Groningen, Netherlands
Local Institution, Stadskanaal, Netherlands
Local Institution, Zeist, Netherlands
Local Institution, Zwolle, Netherlands
Local Institution, Moscow, Russian Federation
Local Institution, St. Petersburg, Russian Federation
Local Institution, Barcelona, Spain
Local Institution, Jerez De La Frontera, Spain
Local Institution, Las Palmas De G. C., Spain
Local Institution, Madrid, Spain
Local Institution, Marbella, Spain
Local Institution, Edmonton, Alberta, Canada
Local Institution, Vancouver, British Columbia, Canada
Local Institution, Tustin, California, United States
Local Institution, Middlesborough, Cleveland, United Kingdom
Local Institution, Belfast, County Durham, United Kingdom
Local Institution, Mexico, Distrito Federal, Mexico
Local Institution, W. Palm Beach, Florida, United States
Local Institution, Miami, Florida, United States
Local Institution, Chicago, Illinois, United States
Local Institution, Guadalajara, Jalisco, Mexico
Local Institution, Winnipeg, Manitoba, Canada
Local Institution, Morelia, Michioacan, Mexico
Local Institution, Burwood, New South Wales, Australia
Local Institution, Camperdown, New South Wales, Australia
Local Institution, Gosford, New South Wales, Australia
Local Institution, St. Leonards, New South Wales, Australia
Local Institution, Flushing, New York, United States
Local Institution, New York, New York, United States
Local Institution, Halifax, Nova Scotia, Canada
Local Institution, Monterrey, Nuevo Leon, Mexico
Local Institution, Cleveland, Ohio, United States
Local Institution, Scarborough, Ontario, Canada
Local Institution, Toronto, Ontario, Canada
Local Institution, Philadelphia, Pennsylvania, United States
Local Institution, Laval, Quebec, Canada
Local Institution, Longueuil, Quebec, Canada
Local Institution, Woolloongabba, Queensland, Australia
Local Institution, Providence, Rhode Island, United States
Local Institution, Mexico, San Lis Potosi, Mexico
Local Institution, San Antonio, Texas, United States
Local Institution, Box Hill, Victoria, Australia
Local Institution, Fitzroy, Victoria, Australia
Local Institution, Parkville, Victoria, Australia
Local Institution, Birmingham, West Midlands, United Kingdom
Local Institution, Derby, West Midlands, United Kingdom
Local Institution, Fremantle, Western Australia, Australia
Local Institution, Milwaukee, Wisconsin, United States
