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.

Condition	Treatment or Intervention	Phase
Albuminuria	Drug: Irbesartan  Drug: ramipril	Phase IV

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

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: a) Diabetes b) Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia c) Artery disease in the legs, limiting walking capacity and/or blood flow in the legs d) 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

BMS Call Center      1-866-892-1BMS  Ext. 148 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 148 

California
      Local Institution, Tustin,  California,  United States; Recruiting
Florida
      Local Institution, W. Palm Beach,  Florida,  United States; Recruiting
      Local Institution, Miami,  Florida,  United States; Not yet recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Recruiting
New York
      Local Institution, Flushing,  New York,  United States; Recruiting
      Local Institution, New York,  New York,  United States; Recruiting
Ohio
      Local Institution, Cleveland,  Ohio,  United States; Recruiting
Pennsylvania
      Local Institution, Philadelphia,  Pennsylvania,  United States; Recruiting
Rhode Island
      Local Institution, Providence,  Rhode Island,  United States; Not yet recruiting
Texas
      Local Institution, San Antonio,  Texas,  United States; Recruiting
Wisconsin
      Local Institution, Milwaukee,  Wisconsin,  United States; Not yet recruiting
Australia, New South Wales
      Local Institution, Burwood,  New South Wales,  Australia; Not yet recruiting
      Local Institution, Camperdown,  New South Wales,  Australia; Not yet recruiting
      Local Institution, Gosford,  New South Wales,  Australia; Not yet recruiting
      Local Institution, St. Leonards,  New South Wales,  Australia; Not yet recruiting
Australia, Queensland
      Local Institution, Woolloongabba,  Queensland,  Australia; Recruiting
Australia, Victoria
      Local Institution, Box Hill,  Victoria,  Australia; Recruiting
      Local Institution, Fitzroy,  Victoria,  Australia; Not yet recruiting
      Local Institution, Parkville,  Victoria,  Australia; Not yet recruiting
Australia, Western Australia
      Local Institution, Fremantle,  Western Australia,  Australia; Not yet recruiting
Canada, Alberta
      Local Institution, Edmonton,  Alberta,  Canada; Recruiting
Canada, British Columbia
      Local Institution, Vancouver,  British Columbia,  Canada; Recruiting
Canada, Manitoba
      Local Institution, Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Nova Scotia
      Local Institution, Halifax,  Nova Scotia,  Canada; Recruiting
Canada, Ontario
      Local Institution, Scarborough,  Ontario,  Canada; Recruiting
      Local Institution, Toronto,  Ontario,  Canada; Recruiting
Canada, Quebec
      Local Institution, Laval,  Quebec,  Canada; Recruiting
      Local Institution, Longueuil,  Quebec,  Canada; Recruiting
France
      Local Institution, Boulogne-sur-Mer,  France; Recruiting
      Local Institution, Colmar,  France; Recruiting
      Local Institution, Grenoble Cedex 9,  France; Recruiting
      Local Institution, Pessac,  France; Recruiting
      Local Institution, Strasbourg,  France; Recruiting
Germany
      Local Institution, Aschaffenburg,  Germany; Recruiting
      Local Institution, Bad Mergentheim,  Germany; Recruiting
      Local Institution, Gottingen,  Germany; Recruiting
      Local Institution, Halle,  Germany; Not yet recruiting
      Local Institution, Kunzing,  Germany; Recruiting
      Local Institution, Munchen,  Germany; Recruiting
      Local Institution, ORNBAU,  Germany; Recruiting
      Local Institution, Vellmar,  Germany; Recruiting
      Local Institution, Villingen-Schwenningen,  Germany; Recruiting
Israel
      Local Institution, Ashkelon,  Israel; Recruiting
      Local Institution, Beer-Sheva,  Israel; Not yet recruiting
      Local Institution, Hadera,  Israel; Recruiting
      Local Institution, Holon,  Israel; Recruiting
      Local Institution, Jerusalem,  Israel; Recruiting
      Local Institution, Kfar Saba,  Israel; Not yet recruiting
      Local Institution, Kiryat Biyalik,  Israel; Not yet recruiting
      Local Institution, Nazaret,  Israel; Recruiting
      Local Institution, RAMAT-GAN,  Israel; Recruiting
      Local Institution, Rehovot,  Israel; Recruiting
      Local Institution, Tel Aviv,  Israel; Recruiting
      Local Institution, Zerifin,  Israel; Recruiting
Italy
      Local Institution, Chieri,  Italy; Not yet recruiting
      Local Institution, Genova,  Italy; Not yet recruiting
      Local Institution, Lecco,  Italy; Recruiting
      Local Institution, Napoli,  Italy; Recruiting
      Local Institution, Rimini,  Italy; Recruiting
      Local Institution, Rome,  Italy; Not yet recruiting
      Local Institution, San Benedetto del Tronto,  Italy; Not yet recruiting
Latvia
      Local Institution, Daugavpils,  Latvia; Recruiting
      Local Institution, Riga,  Latvia; Recruiting
Lithuania
      Local Institution, Kaunas,  Lithuania; Recruiting
      Local Institution, Klaipeda,  Lithuania; Recruiting
      Local Institution, Panevezys,  Lithuania; Recruiting
      Local Institution, Siauliai,  Lithuania; Recruiting
      Local Institution, Vilnius,  Lithuania; Recruiting
Mexico
      Local Institution, Aguascalientes,  Mexico; Recruiting
Mexico, Distrito Federal
      Local Institution, Mexico,  Distrito Federal,  Mexico; Recruiting
Mexico, Jalisco
      Local Institution, Guadalajara,  Jalisco,  Mexico; Recruiting
Mexico, Michioacan
      Local Institution, Morelia,  Michioacan,  Mexico; Recruiting
Mexico, Nuevo Leon
      Local Institution, Monterrey,  Nuevo Leon,  Mexico; Recruiting
Mexico, San Lis Potosi
      Local Institution, Mexico,  San Lis Potosi,  Mexico; Recruiting
Netherlands
      Local Institution, Amsterdam,  Netherlands; Recruiting
      Local Institution, Blaricum,  Netherlands; Recruiting
      Local Institution, Eindhoven,  Netherlands; Recruiting
      Local Institution, Groningen,  Netherlands; Recruiting
      Local Institution, Stadskanaal,  Netherlands; Recruiting
      Local Institution, Zeist,  Netherlands; Recruiting
      Local Institution, Zwolle,  Netherlands; Recruiting
Russian Federation
      Local Institution, Moscow,  Russian Federation; Recruiting
      Local Institution, St Petersburg,  Russian Federation; Not yet recruiting
Spain
      Local Institution, Barcelona,  Spain; Not yet recruiting
      Local Institution, Jerez de la Frontera,  Spain; Not yet recruiting
      Local Institution, Las Palmas De G. C.,  Spain; Not yet recruiting
      Local Institution, Madrid,  Spain; Recruiting
      Local Institution, Marbella,  Spain; Not yet recruiting
United Kingdom, Cleveland
      Local Institution, Middlesborough,  Cleveland,  United Kingdom; Not yet recruiting
United Kingdom, County Durham
      Local Institution, Belfast,  County Durham,  United Kingdom; Not yet recruiting
United Kingdom, West Midlands
      Local Institution, Birmingham,  West Midlands,  United Kingdom; Not yet recruiting
      Local Institution, Derby,  West Midlands,  United Kingdom; Not yet recruiting

Study ID Numbers:  CV131-169
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  November 2, 2004
ClinicalTrials.gov Identifier:  NCT00095290
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08