Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

April 7, 2011 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Other Names:
  • Avapro
Placebo Comparator: A2
Drug: Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in AER from baseline to Week 20

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 2, 2004

First Submitted That Met QC Criteria

November 2, 2004

First Posted (Estimate)

November 3, 2004

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV131-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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