Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery (FCAD02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00838383
First received: February 5, 2009
Last updated: February 2, 2012
Last verified: February 2012

February 5, 2009
February 2, 2012
August 2006
March 2008   (final data collection date for primary outcome measure)
The primary efficacy endpoint is the reduction in PVR. [ Time Frame: at any of the PVR measurements ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00838383 on ClinicalTrials.gov Archive Site
Other safety endpoints. [ Time Frame: Various ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiac Surgery Subjects
  • Subjects Undergoing CABG and/or Cardiac Valve Replacement
  • Drug: sitaxsentan (Thelin)
    sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
    Other Names:
    • sitaxsentan
    • Thelin
  • Drug: sitaxsentan (Thelin)
    sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
    Other Names:
    • sitaxsentan
    • Thelin
  • Drug: Placebo
    Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
    Other Name: Placebo
  • Experimental: sitaxsentan (1.0 mg/kg)
    Intervention: Drug: sitaxsentan (Thelin)
  • Experimental: sitaxsentan (2.0 mg/kg)
    Intervention: Drug: sitaxsentan (Thelin)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).

Exclusion Criteria:

  • Requires an emergent or "emergency" CABG and/or cardiac valve replacement.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838383
B1321004, B1321004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP