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Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

Last updated on January 19, 2020

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Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Requires an emergent or "emergency" CABG and/or cardiac valve replacement.

NCT00838383
Pfizer
Completed
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

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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

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