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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Surgery Subjects
Subjects Undergoing CABG and/or Cardiac Valve Replacement
 Drug: sitaxsentan (Thelin)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective Endothelin Type A Receptor Inhibition In Cardiac Surgery Subjects With Pre-Existing Cardiovascular Risk Factors: A Dose Confirmation Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary efficacy endpoint is the reduction in PVR. [ Time Frame: at any of the PVR measurements ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Other safety endpoints. [ Time Frame: Various ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sitaxsentan (1.0 mg/kg) Drug: sitaxsentan (Thelin)
sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
Other Names:
  • sitaxsentan
  • Thelin
Experimental: sitaxsentan (2.0 mg/kg) Drug: sitaxsentan (Thelin)
sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
Other Names:
  • sitaxsentan
  • Thelin
Placebo Comparator: Placebo Drug: Placebo
Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
Other Name: Placebo

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838383

Locations
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838383     History of Changes
Other Study ID Numbers: B1321004, B1321004
Study First Received: February 5, 2009
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
multi-center, placebo-controlled, randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB

ClinicalTrials.gov processed this record on June 17, 2013