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Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

Last updated on October 5, 2018

FOR MORE INFORMATION
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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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
Intervention Model: Parallel Assignment
Masking: None (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.
  • 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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00838383
B1321004
B1321004
No
Not Provided
Not Provided
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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