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NCT00458276 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT00458276: Clinical Trial Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT00458276 is a Phase 3 study that was terminated before completion, run by Idorsia Pharmaceuticals. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458276, a Phase 3 study, was terminated before completion, sponsored by Idorsia Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study Summary
Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.
Interventions
- DRUG placebo
- DRUG tezosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
Why NCT00458276 stopped before completion
NCT00458276 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00458276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458276 about?
NCT00458276 is a clinical study titled "Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery". Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the ...
What is the current status of trial NCT00458276?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2007-04. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00458276?
The interventions under investigation include: placebo (DRUG), tezosentan (DRUG).
Who is sponsoring clinical trial NCT00458276?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458276's enrollment target sits among peer trials
274 1207th of 2000 higher than 788 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
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