Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00838383

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 Drug: Sitaxsentan (2.0 mg/kg) Drug: Placebo	Phase II

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Selective Endothelin Type A Receptor Inhibition In Cardiac Surgery Subjects With Pre-Existing Cardiovascular Risk Factors: A Dose Confirmation Study

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
Sitaxsentan (1.0 mg/kg): Experimental Sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug: Sitaxsentan Sitaxsentan (1.0 mg/kg)
Sitaxsentan (2.0 mg/kg): Experimental Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug: Sitaxsentan (2.0 mg/kg) Sitaxsentan (2.0 mg/kg)
Placebo: Placebo Comparator Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug: Placebo 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

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1321004, B1321004
Study First Received:	February 5, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00838383 History of Changes
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 May 06, 2009