Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

March 18, 2015 updated by: Bristol-Myers Squibb
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4128

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Cordoba, Argentina
        • Local Institution
      • Corrientes, Argentina
        • Local Institution
      • Mendoza, Argentina
        • Local Institution
    • Buenos Aires
      • San Martin, Buenos Aires, Argentina
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia
        • Local Institution
      • Concord, New South Wales, Australia
        • Local Institution
      • Garran, New South Wales, Australia
        • Local Institution
      • Kogarah, New South Wales, Australia
        • Local Institution
      • Randwick, New South Wales, Australia
        • Local Institution
    • Queensland
      • Auchenflower, Queensland, Australia
        • Local Institution
      • Brisbane, Queensland, Australia
        • Local Institution
      • Woolloongabba, Queensland, Australia
        • Local Institution
    • Tasmania
      • Launceston, Tasmania, Australia
        • Local Institution
    • Victoria
      • Geelong, Victoria, Australia
        • Local Institution
      • Prahran, Victoria, Australia
        • Local Institution
  • Belgium
      • AYE, Belgium
        • Local Institution
      • Aalst, Belgium
        • Local Institution
      • Borgerhout, Belgium
        • Local Institution
      • Genk-waterschei, Belgium
        • Local Institution
      • Gent, Belgium
        • Local Institution
      • HUY, Belgium
        • Local Institution
      • Hasselt, Belgium
        • Local Institution
      • Leuven, Belgium
        • Local Institution
      • Verviers, Belgium
        • Local Institution
  • Brazil
      • Rio de Janeiro, Brazil
        • Local Institution
    • Bahia
      • Salvador, Bahia, Brazil
        • Local Institution
    • Goias
      • Goiania-go, Goias, Brazil
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Local Institution
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil
        • Local Institution
      • Sao Paulo, Sp, Sao Paulo, Brazil
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Local Institution
    • British Columbia
      • Victoria, British Columbia, Canada
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada
        • Local Institution
      • Hamilton, Ontario, Canada
        • Local Institution
      • Rexdale, Ontario, Canada
        • Local Institution
      • Scarborough, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
      • Weston, Ontario, Canada
        • Local Institution
    • Quebec
      • Longueuil, Quebec, Canada
        • Local Institution
      • Montreal, Quebec, Canada
        • Local Institution
      • St-Lambert, Quebec, Canada
        • Local Institution
      • Ste-Foy, Quebec, Canada
        • Local Institution
  • Czech Republic
      • Prague 2, Czech Republic
        • Local Institution
      • Prague 4, Czech Republic
        • Local Institution
      • Prague 9, Czech Republic
        • Local Institution
      • Usti Nad Labem, Czech Republic
        • Local Institution
  • Denmark
      • Copenhagen, Denmark
        • Local Institution
      • Copenhagen Nv, Denmark
        • Local Institution
  • France
      • Abbeville, France
        • Local Institution
      • Cholet, France
        • Local Institution
      • DAX, France
        • Local Institution
      • GAP, France
        • Local Institution
      • Langres, France
        • Local Institution
      • Lille, France
        • Local Institution
      • Montbeliard, France
        • Local Institution
      • Paris Cedex 13, France
        • Local Institution
      • Poissy, France
        • Local Institution
      • Pontoise, France
        • Local Institution
      • Provins, France
        • Local Institution
      • Roubaix, France
        • Local Institution
      • Rouen, France
        • Local Institution
      • Saint Malo, France
        • Local Institution
      • Tours, France
        • Local Institution
      • Vandoeuvre Les Nancy, France
        • Local Institution
      • Vichy Cedex, France
        • Local Institution
  • Germany
      • Bad Homburg, Germany
        • Local Institution
      • Berlin, Germany
        • Local Institution
      • Goettingen, Germany
        • Local Institution
      • Gunzenhausen, Germany
        • Local Institution
      • Halle, Germany
        • Local Institution
      • Homburg / Saar, Germany
        • Local Institution
      • Jena, Germany
        • Local Institution
      • Langen, Germany
        • Local Institution
      • Leipzig, Germany
        • Local Institution
      • Mainz, Germany
        • Local Institution
      • Marburg, Germany
        • Local Institution
      • Muenchen, Germany
        • Local Institution
      • Regensburg, Germany
        • Local Institution
      • Stuttgart, Germany
        • Local Institution
      • Witten, Germany
        • Local Institution
      • Wuerzburg, Germany
        • Local Institution
  • Greece
      • Athens, Greece
        • Local Institution
      • Patras, Greece
        • Local Institution
  • Hungary
      • Budapest, Hungary
        • Local Institution
      • Debrecen, Hungary
        • Local Institution
      • Siofok, Hungary
        • Local Institution
      • Szeged, Hungary
        • Local Institution
  • Ireland
      • Dublin, Ireland
        • Local Institution
    • Dublin
      • County Dublin, Dublin, Ireland
        • Local Institution
  • Italy
      • Ascoli Piceno, Italy
        • Local Institution
      • Bologna, Italy
        • Local Institution
      • Brescia, Italy
        • Local Institution
      • Cosenza, Italy
        • Local Institution
      • Pavia, Italy
        • Local Institution
      • Perugia, Italy
        • Local Institution
      • Piacenza, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
      • Siena, Italy
        • Local Institution
      • Trieste, Italy
        • Local Institution
      • Udine, Italy
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Local Institution
    • Nuevo Leon
      • San Pedro Garza Garcia, Nuevo Leon, Mexico
        • Local Institution
  • Netherlands
      • Alkmaar, Netherlands
        • Local Institution
      • Almere, Netherlands
        • Local Institution
      • Amersfoort, Netherlands
        • Local Institution
      • Apeldoorn, Netherlands
        • Local Institution
      • Assen, Netherlands
        • Local Institution
      • Breda, Netherlands
        • Local Institution
      • Delft, Netherlands
        • Local Institution
      • Emmen, Netherlands
        • Local Institution
      • Gorinchem, Netherlands
        • Local Institution
      • Groningen, Netherlands
        • Local Institution
      • Heemstede, Netherlands
        • Local Institution
      • Helmond, Netherlands
        • Local Institution
      • Hengelo Ov, Netherlands
        • Local Institution
      • Nijmegen, Netherlands
        • Local Institution
      • Rotterdam, Netherlands
        • Local Institution
      • Sittard, Netherlands
        • Local Institution
      • Sneek, Netherlands
        • Local Institution
      • Veldhoven, Netherlands
        • Local Institution
      • Vlaardingen, Netherlands
        • Local Institution
      • Zaandam, Netherlands
        • Local Institution
  • Norway
      • Baerum Postterminal, Norway
        • Local Institution
      • Stavanger, Norway
        • Local Institution
      • Tonsberg, Norway
        • Local Institution
  • Poland
      • Bydgoszcz, Poland
        • Local Institution
      • Katowice, Poland
        • Local Institution
      • Piotrkow Tryb., Poland
        • Local Institution
      • Stalowa Wola, Poland
        • Local Institution
      • Warszawa, Poland
        • Local Institution
      • Wroclaw, Poland
        • Local Institution
  • Portugal
      • Lisbon, Portugal
        • Local Institution
      • Matosinhos, Portugal
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation
        • Local Institution
      • Saratov, Russian Federation
        • Local Institution
      • St. Petersburg, Russian Federation
        • Local Institution
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Local Institution
      • Morningside, Gauteng, South Africa
        • Local Institution
      • Parktown West, Gauteng, South Africa
        • Local Institution
    • Kwa Zulu Natal
      • Berea, Kwa Zulu Natal, South Africa
        • Local Institution
      • Congella, Kwa Zulu Natal, South Africa
        • Local Institution
  • Spain
      • A Coruna, Spain
        • Local Institution
      • Barcelona, Spain
        • Local Institution
      • Cordoba, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Malaga, Spain
        • Local Institution
      • Murcia, Spain
        • Local Institution
      • Palma de Mallorca, Spain
        • Local Institution
      • Sevilla, Spain
        • Local Institution
      • Valencia, Spain
        • Local Institution
      • Zaragoza, Spain
        • Local Institution
  • Sweden
      • Falun, Sweden
        • Local Institution
      • Gothenburg, Sweden
        • Local Institution
      • Linkoping, Sweden
        • Local Institution
      • Malmo, Sweden
        • Local Institution
      • Skelleftea, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
      • Sundsvall, Sweden
        • Local Institution
  • Switzerland
      • Bellinzona, Switzerland
        • Local Institution
      • Liestal, Switzerland
        • Local Institution
      • Zuerich, Switzerland
        • Local Institution
  • United Kingdom
      • Dundee, United Kingdom
        • Local Institution
      • Londonderry, United Kingdom
        • Local Institution
    • Dumbartonshire
      • Glasgow, Dumbartonshire, United Kingdom
        • Local Institution
    • Essex
      • Romford, Essex, United Kingdom
        • Local Institution
    • Yorkshire
      • Hull, Yorkshire, United Kingdom
        • Local Institution
      • York, Yorkshire, United Kingdom
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
    • Arizona
      • Peoria, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Los Angeles, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • San Francisco, California, United States
        • Local Institution
    • Connecticut
      • Farmington, Connecticut, United States
        • Local Institution
    • Florida
      • Jacksonville, Florida, United States
        • Local Institution
      • Jacksonville Beach, Florida, United States
        • Local Institution
      • Lake Worth, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
      • Vero Beach, Florida, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
      • Peoria, Illinois, United States
        • Local Institution
    • Indiana
      • Jeffersonville, Indiana, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Louisiana
      • Chalmette, Louisiana, United States
        • Local Institution
      • Shreveport, Louisiana, United States
        • Local Institution
    • Maine
      • Auburn, Maine, United States
        • Local Institution
    • Maryland
      • Takoma Park, Maryland, United States
        • Local Institution
      • Towson, Maryland, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
      • Haverhill, Massachusetts, United States
        • Local Institution
      • Natick, Massachusetts, United States
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States
        • Local Institution
      • Petoskey, Michigan, United States
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • Nebraska
      • Omaha, Nebraska, United States
        • Local Institution
    • Nevada
      • Reno, Nevada, United States
        • Local Institution
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Local Institution
    • New Jersey
      • Elmer, New Jersey, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • New York
      • Albany, New York, United States
        • Local Institution
      • Bronx, New York, United States
        • Local Institution
      • East Syracuse, New York, United States
        • Local Institution
      • Flushing, New York, United States
        • Local Institution
      • Rochester, New York, United States
        • Local Institution
      • Troy, New York, United States
        • Local Institution
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Local Institution
      • Concord, North Carolina, United States
        • Local Institution
      • Durham, North Carolina, United States
        • Local Institution
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Ohio
      • Canton, Ohio, United States
        • Local Institution
      • Cincinnati, Ohio, United States
        • Local Institution
      • Columbus, Ohio, United States
        • Local Institution
      • Lorain, Ohio, United States
        • Local Institution
      • Sandusky, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Flourtown, Pennsylvania, United States
        • Local Institution
      • Lancaster, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Tennessee
      • Germantown, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
    • Virginia
      • Lynchberg, Virginia, United States
        • Local Institution
      • Richmond, Virginia, United States
        • Local Institution
      • South Boston, Virginia, United States
        • Local Institution
    • Washington
      • Spokane, Washington, United States
        • Local Institution
    • Wisconsin
      • Madison, 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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
  • Left ventricular ejection fraction (LVEF) > = 45%
  • Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Exclusion Criteria:

  • Acute myocardial infarction within 3 months;
  • Heart revascularization procedure within 3 months;
  • Hospitalization for angina within 3 months;
  • Other heart surgery
  • Life-threatening or uncontrolled arrhythmia
  • Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
  • Stroke or surgery of the arteries in the brain within 3 months;
  • Serious lung disease which requires use of home oxygen.
  • Significantly low blood pressure
  • Significantly high blood pressure
  • Other known diseases that may limit life expectancy to <3 years;
  • Known or suspected bilateral kidney artery narrowing;
  • Geographic or social factors making study participation and follow-up impractical.

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
Placebo Comparator: 2
Drug: Placebo
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Active Comparator: 1
Drug: Irbesartan
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
Year 1, Year 2, Year 3, Year 4, Year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Year 1, Year 2, Year 3, Year 4, Year 5
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Time Frame: Baseline, Month 6, Month 14
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Baseline, Month 6, Month 14
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Time Frame: Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Time Frame: Baseline, Month 6, Month 14
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
Baseline, Month 6, Month 14
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to cardiovascular death
Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing All-cause Death at Given Time Points
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to all-cause death
Year 1, Year 2, Year 3, Year 4, Year 5
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
Time Frame: Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Time Frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Time Frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Time Frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Time Frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Year 1, Year 2, Year 3, Year 4, Year 5
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Time Frame: Baseline, Month 6, Month 18, Month 30
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Baseline, Month 6, Month 18, Month 30
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Time Frame: Baseline, Month 42, Month 54, Month 66
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Baseline, Month 42, Month 54, Month 66
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Time Frame: Baseline, Final Visit
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.
Baseline, Final Visit

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

June 1, 2002

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 1, 2004

First Submitted That Met QC Criteria

November 1, 2004

First Posted (Estimate)

November 2, 2004

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV131-148

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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