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NCT00838383 · ClinicalTrials.gov registry record · Phase 2
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT00838383: Completed Phase 2 study, sponsored by Pfizer.
NCT00838383 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00838383, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.
Primary Outcome
PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participant
Interventions
- DRUG Placebo
- DRUG sitaxsentan (Thelin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-08-10 |
| Est. Completion | 2008-03-31 |
| Phase | Phase 2 |
What the finished NCT00838383 record still lists
NCT00838383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00838383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00838383 about?
NCT00838383 is a clinical study titled "Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery". This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.
What is the current status of trial NCT00838383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2006-08-10. Estimated completion is 2008-03-31.
What interventions are being tested in trial NCT00838383?
The interventions under investigation include: Placebo (DRUG), sitaxsentan (Thelin) (DRUG).
Who is sponsoring clinical trial NCT00838383?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00838383's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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