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COMPLETED 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

NCT00910962 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 526 participants
Start Date 2009-10-08
Est. Completion 2012-03-06
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00910962

The ClinicalTrials.gov registry entry for NCT00910962 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00910962 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00910962?

The interventions under investigation include: Placebo (DRUG), GW856553 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00910962?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial