Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised,double-blind, parallel group, placebo-controlled, multicentre study to evaluate the safety, tolerability and efficacy of oral GW677954 capsules 2.5mg, 5mg, 10mg and 20mg a day for 24 weeks in overweight dyslipidaemic subjects
Trial description: Study in patients with dyslipidaemia.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
290
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Metabolic Syndrome X
Product
sodelglitazar
Collaborators
Not applicable
Study date(s)
December 2005 to June 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Waist circumference =102cm (men) or =88cm (women) at visit 1.
- History of diabetes
- History of cardiovascular disease
Inclusion and exclusion criteria
Inclusion criteria:
- Waist circumference =102cm (men) or =88cm (women) at visit 1.
- Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1.
- Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1.
- Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.
Exclusion criteria:
- History of diabetes
- History of cardiovascular disease
- Diagnosis of genetic lipid disorders
- History of muscle pain
- History of cancer
Trial location(s)
Location
GSK Investigational Site
Meadowbrook, Queensland, Australia, 4131
Status
Study Complete
Showing 1 - 6 of 50 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-25-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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