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History of Changes for Study: NCT00318617
Effect Of GW501516X On How The Heart Obtains And Uses Energy
Latest version (submitted March 15, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 25, 2006 None (earliest Version on record)
2 January 30, 2007 Recruitment Status, Study Status, Contacts/Locations and Conditions
3 October 6, 2008 Contacts/Locations, Study Status and Sponsor/Collaborators
4 March 15, 2012 Study Design, Sponsor/Collaborators, Study Status, Contacts/Locations, Conditions and Study Identification
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Study NCT00318617
Submitted Date:  April 25, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: PAD100964
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2006
Overall Status: Recruiting
Study Start: December 2005
Primary Completion:
Study Completion:
First Submitted: April 25, 2006
First Submitted that
Met QC Criteria:
April 25, 2006
First Posted: April 27, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 25, 2006
Last Update Posted: April 27, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: GlaxoSmithKline
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Heart Failure
Keywords: Heart Failure
peroxisome proliferator activated receptors
PPARs
PPAR
MRI
fatty acid metabolism
cardiac energetics
GW501516X
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 30
Open or close this module Arms and Interventions
Intervention Details:
Drug: GW510516X
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.
Secondary Outcome Measures:
1. Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 40 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Study Officials: GSK Clinical Trial, MD
Study Chair
GlaxoSmithKline
Locations: United States, Pennsylvania
GSK Clinical Trials Call Center
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Thomas Cappola 877-379-3718
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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