Trials / Completed
CompletedNCT01357850
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK716155 | GSK716155 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2010-09-15
- Primary completion
- 2012-09-18
- Completion
- 2012-09-18
- First posted
- 2011-05-23
- Last updated
- 2017-08-17
- Results posted
- 2014-10-01
Locations
15 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01357850. Inclusion in this directory is not an endorsement.