Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery (FCAD02)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Cardiac Surgery Subjects; Subjects Undergoing CABG and/or Cardiac Valve Replacement

Treatments: Drug: sitaxsentan (Thelin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838383

FCAD02-CARDIAC SURGERY (Other Identifier)

B1321004

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 48 to 82 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups, including a placebo group

sitaxsentan (1.0 mg/kg)

Experimental group

Treatment:

Drug: sitaxsentan (Thelin)

Drug: sitaxsentan (Thelin)

sitaxsentan (2.0 mg/kg)

Experimental group

Treatment:

Drug: sitaxsentan (Thelin)

Drug: sitaxsentan (Thelin)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo