Effect Of GW501516X On How The Heart Obtains And Uses Energy
This study has been terminated.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318617
First received: April 25, 2006
Last updated: March 15, 2012
Last verified: February 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 25, 2006 | ||||
| Last Updated Date | March 15, 2012 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Energy-related chemicals and heart contraction, determined by MRI measurement of the heart. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00318617 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect Of GW501516X On How The Heart Obtains And Uses Energy | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: GW510516X
Other Name: GW510516X |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00318617 | ||||
| Other Study ID Numbers ICMJE | PAD100964 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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