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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

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The primary efficacy endpoint is the reduction in PVR. [ Time Frame: at any of the PVR measurements ]

Secondary Outcome Measures :
  1. Other safety endpoints. [ Time Frame: Various ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838383     History of Changes
Other Study ID Numbers: B1321004
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action