CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
sitaxsentan (Thelin) +2 moredrug
Likely dose
Sitaxsentan 1.0 mg/kg or 2.0 mg/kg administered immediately following cross-clamp release and 12 hours post-CPBAI-extracted
Key inclusion· 1
  • ✓Scheduled for CABG, aortic/mitral valve replacement, or combined CABG and valve replacement requiring cardiopulmonary bypass (CPB)
Key exclusion· 1
  • ✕Emergency or urgent CABG and/or valve replacement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00838383
NCT00838383Phase 2Completed
CompareCT.gov

SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY

Pfizer·interventional·Posted Feb 6, 2009·Updated Sep 8, 2022

In Brief

A Phase 2 clinical trial evaluating sitaxsentan (Thelin) and Placebo for Cardiac Surgery Subjects and Subjects Undergoing CABG and/or Cardiac Valve Replacement. Completed, enrolled 29 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2009
Enrollment StartAug 10, 2006
Primary CompletionMar 31, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago

Interventions

sitaxsentan (Thelin)drug

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

sitaxsentan (Thelin)drug

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

Placebodrug

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