Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095290
First received: November 2, 2004
Last updated: April 7, 2011
Last verified: September 2008
  Purpose

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 Intervention Phase
Albuminuria
Drug: Ramipril + Irbesartan
Drug: Ramipril + Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Irbesartan Versus Placebo in Combination With Standard Cardiovascular Protection ACE-I Therapy With Ramipril for the Treatment of Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in AER from baseline to Week 20

Secondary Outcome Measures:
  • Change from baseline in seated systolic and diastolic blood pressures at Week 20; Comparison of change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups

Estimated Enrollment: 400
Study Start Date: September 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Other Name: Avapro
Placebo Comparator: A2 Drug: Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095290

  Hide Study Locations
Locations
United States, California
Local Institution
Tustin, California, United States
United States, Florida
Local Institution
Miami, Florida, United States
Local Institution
W. Palm Beach, Florida, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, New York
Local Institution
Flushing, New York, United States
Local Institution
New York, New York, United States
United States, Ohio
Local Institution
Cleveland, Ohio, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Local Institution
Providence, Rhode Island, United States
United States, Texas
Local Institution
San Antonio, Texas, United States
United States, Wisconsin
Local Institution
Milwaukee, Wisconsin, United States
Australia, New South Wales
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
Australia, Queensland
Local Institution
Woolloongabba, Queensland, Australia
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia
Local Institution
Fitzroy, Victoria, Australia
Local Institution
Parkville, Victoria, Australia
Australia, Western Australia
Local Institution
Fremantle, Western Australia, Australia
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada
Canada, Ontario
Local Institution
Scarborough, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Canada, Quebec
Local Institution
Laval, Quebec, Canada
Local Institution
Longueuil, Quebec, Canada
France
Local Institution
Boulogne Sur Mer, France
Local Institution
Colmar, France
Local Institution
Grenoble Cedex 9, France
Local Institution
Pessac, France
Local Institution
Strasbourg, France
Germany
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
Israel
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
Italy
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
Latvia
Local Institution
Daugavpils, Latvia
Local Institution
Riga, Latvia
Lithuania
Local Institution
Kaunas, Lithuania
Local Institution
Klaipeda, Lithuania
Local Institution
Panevezys, Lithuania
Local Institution
Siauliai, Lithuania
Local Institution
Vilnius, Lithuania
Mexico
Local Institution
Mexico, Distrito Federal, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Morelia, Michioacan, Mexico
Local Institution
Monterrey, Nuevo Leon, Mexico
Local Institution
Mexico, San Lis Potosi, Mexico
Local Institution
Aguascalientes, Mexico
Netherlands
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
Russian Federation
Local Institution
Moscow, Russian Federation
Local Institution
St. Petersburg, Russian Federation
Spain
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
United Kingdom
Local Institution
Middlesborough, Cleveland, United Kingdom
Local Institution
Belfast, County Durham, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Local Institution
Derby, West Midlands, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00095290     History of Changes
Other Study ID Numbers: CV131-169
Study First Received: November 2, 2004
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Albuminuria
Hypertension
Elevated Cardiovascular Risk
Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

Additional relevant MeSH terms:
Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Irbesartan
Ramipril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014