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Effect Of GW501516X On How The Heart Obtains And Uses Energy

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ClinicalTrials.gov Identifier: NCT00318617
Recruitment Status : Terminated
First Posted : April 27, 2006
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

Tracking Information
First Submitted Date April 25, 2006
First Posted Date April 27, 2006
Last Update Posted Date March 19, 2012
Study Start Date December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 25, 2006)
Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2006)
Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Effect Of GW501516X On How The Heart Obtains And Uses Energy
Official Title A Two Part Study to Separately Evaluate the Effect of 4-week Treatment With GW501516X Relative to Placebo on Cardiac Energetics in a Randomized, Single-blind, Repeat Dose, Parallel Group Design in Healthy Male Subjects
Brief Summary The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
  • Dyslipidaemias
  • Heart Failure
Intervention Drug: GW510516X
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
 (submitted: April 25, 2006)
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion criteria:

  • Non-smoking.
  • Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches).

Exclusion criteria:

  • History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease).
  • Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.
Sexes Eligible for Study: Male
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00318617
Other Study ID Numbers PAD100964
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Not Provided
Current Study Sponsor GlaxoSmithKline
Original Study Sponsor Same as current
Collaborators Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2011