CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,128 enrolled
Drug / intervention
Irbesartan +1 moredrug
Likely dose
Irbesartan titrated from 75 to 300 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Age ≥60 years with current heart failure symptoms NYHA class II–IV
  • ✓Left ventricular ejection fraction ≥45%
  • ✓Hospitalization for heart failure within past 6 months OR cardiac imaging/ECG abnormalities indicating heart disease
Key exclusion· 9
  • ✕Acute myocardial infarction within 3 months
  • ✕Heart revascularization procedure within 3 months
  • ✕Hospitalization for angina within 3 months
  • ✕Life-threatening or uncontrolled arrhythmia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00095238
NCT00095238Phase 3Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Nov 2, 2004·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating Irbesartan and Placebo for Congestive Heart Failure. Completed, enrolled 4,128 participants across 229 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesArgentina, 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, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2004
Enrollment StartJun 1, 2002
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 21.7 years ago

Interventions

Irbesartandrug

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

Placebodrug

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