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COMPLETED 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

NCT01357850 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 82 participants
Start Date 2010-09-15
Est. Completion 2012-09-18
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01357850

The ClinicalTrials.gov registry entry for NCT01357850 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 82 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 Heart Failure, Congestive 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: NCT01357850 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Pennsylvania, Other, Georgia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01357850?

The interventions under investigation include: Placebo (DRUG), GSK716155 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01357850?

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 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.

Related

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