CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 526 enrolled
Drug / intervention
GW856553 +2 moredrug
Likely dose
GW856553 7.5 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/NCT00910962
NCT00910962Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation

GlaxoSmithKline·interventional·Posted Jun 1, 2009·Updated Dec 7, 2017

In Brief

A Phase 2 clinical trial evaluating GW856553 and Placebo for Acute Coronary Syndrome. Completed, enrolled 526 participants across 108 sites in 9 countries.

Detailed Summary

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesAustralia, Canada, Germany, India, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2009
Enrollment StartOct 8, 2009
Primary CompletionMar 6, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.1 years ago

Interventions

GW856553drug

7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID

GW856553drug

15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID

Placebodrug

Placebo