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NCT00910962 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Acute Coronary Syndrome, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 526
- Enrollment target
- 20
- Study locations
NCT00910962: Completed Phase 2 study of Acute Coronary Syndrome, sponsored by GlaxoSmithKline.
NCT00910962 is a Phase 2 study of Acute Coronary Syndrome that has completed, run by GlaxoSmithKline. The registered enrollment target is 526 participants, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00910962, a Phase 2 study of Acute Coronary Syndrome, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 526 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GW856553
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Mission Viejo
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - St. Petersburg
Minnesota
- GSK Investigational Site - Minneapolis
- GSK Investigational Site - Rochester
New York
- GSK Investigational Site - Brooklyn
- GSK Investigational Site - Stony Brook
North Carolina
- GSK Investigational Site - Durham
- GSK Investigational Site - Raleigh
Pennsylvania
- GSK Investigational Site - Allentown
- GSK Investigational Site - Camp Hill
Alaska
- GSK Investigational Site - Anchorage
Arizona
- GSK Investigational Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2009-10-08 |
| Est. Completion | 2012-03-06 |
| Phase | Phase 2 |
What the finished NCT00910962 record still lists
NCT00910962 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00910962 names 20 study sites across 14 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00910962 about?
NCT00910962 is a clinical study titled "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". 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 ...
What is the current status of trial NCT00910962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 526 participants. The study started on 2009-10-08. Estimated completion is 2012-03-06.
What conditions does trial NCT00910962 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT00910962?
The interventions under investigation include: Placebo (DRUG), GW856553 (DRUG).
Who is sponsoring clinical trial NCT00910962?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00910962 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00910962's enrollment target sits among peer trials
526 17th of 40 higher than 24 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Coronary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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