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Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

NCT00838383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-09-08

Study results available
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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.

Conditions

  • Cardiac Surgery Subjects
  • Subjects Undergoing CABG and/or Cardiac Valve Replacement

Interventions

DRUG

sitaxsentan (Thelin)

sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.

DRUG

sitaxsentan (Thelin)

Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.

DRUG

Placebo

Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-10
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838383 on ClinicalTrials.gov