Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00095238 · ClinicalTrials.gov registry record · Phase 3
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,128
- Enrollment target
NCT00095238: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00095238 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 4,128 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (435% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095238, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,128 participants
- Enrollment target
Study 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.
Primary Outcome
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 o
Interventions
- DRUG Placebo
- DRUG Irbesartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,128 participants |
| Start Date | 2002-06 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00095238 record still lists
NCT00095238 is an interventional study that assigns participants to a tested intervention. Its 4,128 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (435% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00095238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095238 about?
NCT00095238 is a clinical study titled "Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)". 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.
What is the current status of trial NCT00095238?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,128 participants. The study started on 2002-06. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00095238?
The interventions under investigation include: Placebo (DRUG), Irbesartan (DRUG).
Who is sponsoring clinical trial NCT00095238?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00095238's enrollment target sits among peer trials
4,128 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03388606 · 4,100 participants
Characterization and Treatment of Adolescent Depression
- NCT06593353 · 4,165 participants · NA
Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
- NCT02693535 · 4,200 participants · Phase 2
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
- NCT05969028 · 4,200 participants · NA
First Responder Airway & Compression Rate Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia