Trials / Completed
CompletedNCT00838383
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 48 Years – 82 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sitaxsentan (Thelin) | sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. |
| DRUG | sitaxsentan (Thelin) | Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. |
| DRUG | Placebo | Placebo will begin immediately following cross-clamp release and 12 hours post-CPB. |
Timeline
- Start date
- 2006-08-10
- Primary completion
- 2008-03-31
- Completion
- 2008-03-31
- First posted
- 2009-02-06
- Last updated
- 2022-09-08
- Results posted
- 2022-09-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00838383. Inclusion in this directory is not an endorsement.