Last updated: 11/04/2018 10:11:46
Effect Of GW501516X On How The Heart Obtains And Uses Energy
GSK study ID
PAD100964
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Discontinued
Discontinued
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW510516X
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dyslipidaemias, Heart Failure
Product
GW501516, GW590735
Collaborators
Not applicable
Study date(s)
December 2005 to May 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- 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).
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
PHILADELPHIA, Pennsylvania, United States, 19104
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Discontinued
Actual primary completion date
Not applicable
Actual study completion date
2006-10-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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