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A 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

NCT00910962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2017-12-07

Study results available
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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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

GW856553

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

DRUG

GW856553

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-08
Primary Completion
2012-03-06
Completion
2012-03-06

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • India
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT00910962 on ClinicalTrials.gov