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NCT01357850 · ClinicalTrials.gov registry record · Phase 2
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
A Phase 2 study of Heart Failure, Congestive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 15
- Study locations
NCT01357850: Completed Phase 2 study of Heart Failure, Congestive, sponsored by GlaxoSmithKline.
NCT01357850 is a Phase 2 study of Heart Failure, Congestive that has completed, run by GlaxoSmithKline. The registered enrollment target is 82 participants, below the 673-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (88% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357850, a Phase 2 study of Heart Failure, Congestive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 15
- Study locations
Study Summary
This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, resulting in increased myocardial efficiency and increased exercise capacity. A positive result, defined as either statistically significant effects on one or more of the efficacy endpoints or as an overall signal suggesting a clinically relevant effect on myocardial physiology, would provide evidence for potential progression into further development in a chronic heart failure population.
Primary Outcome
FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GSK716155
Study Locations (15)
Pennsylvania
- GSK Investigational Site - New York
- GSK Investigational Site - Philadelphia
Other
- GSK Investigational Site - London
- GSK Investigational Site - Oxford
Georgia
- GSK Investigational Site - Savannah
Louisiana
- GSK Investigational Site - Metairie
Maine
- GSK Investigational Site - Auburn
Maryland
- GSK Investigational Site - Baltimore
Michigan
- GSK Investigational Site - Detroit
Minnesota
- GSK Investigational Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2010-09-15 |
| Est. Completion | 2012-09-18 |
| Phase | Phase 2 |
What the finished NCT01357850 record still lists
NCT01357850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 673-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Heart Failure, Congestive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01357850 lists 15 locations in 13 states (Pennsylvania, Other, Georgia).
Frequently Asked Questions
What is clinical trial NCT01357850 about?
NCT01357850 is a clinical study titled "A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure". This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, ...
What is the current status of trial NCT01357850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2010-09-15. Estimated completion is 2012-09-18.
What conditions does trial NCT01357850 study?
This clinical trial studies the following conditions: Heart Failure, Congestive.
What interventions are being tested in trial NCT01357850?
The interventions under investigation include: Placebo (DRUG), GSK716155 (DRUG).
Who is sponsoring clinical trial NCT01357850?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01357850 being conducted?
This trial has 15 study locations across Georgia, Louisiana, Maine, Maryland, Michigan. 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 NCT01357850's enrollment target sits among peer trials
82 26th of 39 higher than 14 of 39 other Heart Failure, Congestive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure, Congestive 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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