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Trial record 1 of 1 for:    NCT00838383
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Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery (FCAD02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00838383
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 5, 2009
First Posted Date  ICMJE February 6, 2009
Last Update Posted Date February 7, 2012
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
The primary efficacy endpoint is the reduction in PVR. [ Time Frame: at any of the PVR measurements ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00838383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
Other safety endpoints. [ Time Frame: Various ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
Official Title  ICMJE Selective Endothelin Type A Receptor Inhibition In Cardiac Surgery Subjects With Pre-Existing Cardiovascular Risk Factors: A Dose Confirmation Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Surgery Subjects
  • Subjects Undergoing CABG and/or Cardiac Valve Replacement
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838383
Other Study ID Numbers  ICMJE B1321004
B1321004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

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