CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
darusentan 100 mgdrug
Likely dose
darusentan 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00738049
NCT00738049Phase 2Completed
CompareCT.gov

A Phase 2, Investigator-Initiated, Feasibility Study to Evaluate the Mechanisms of Coronary Endothelial Dysfunction Imaged As Resting Myocardial Perfusion Heterogeneity After Endothelin Receptor Blockade With Darusentan

K.Lance Gould·interventional·Posted Aug 20, 2008·Updated Aug 15, 2014

In Brief

A Phase 2 clinical trial evaluating darusentan 100 mg for Coronary Artery Disease and Endothelial Dysfunction. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The primary objective of this study is to test the hypothesis that myocardial perfusion heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images, will improve in a quantitative manner after treatment with selective ETA receptor antagonist darusentan 100 mg per day for 2 weeks compared to baseline and post-treatment PET scans in clinically stable subjects with coronary atherosclerosis and/or risk factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Endothelial Dysfunction
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 20, 2008
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.9 years ago

Interventions

darusentan 100 mgdrug

All subjects will receive oral darusentan 100 mg for a total of 2 weeks and placebo for 2 weeks.