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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Change in AER from baseline to Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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