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

NCT00095238 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4128

Last updated 2015-04-07

Study results available
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Summary

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.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Irbesartan

Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

DRUG

Placebo

Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00095238 on ClinicalTrials.gov