Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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:
Drug: GW677954
Enrollment:
290
Observational study model:
Not applicable
Primary completion date:
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
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Elizabeth Vale, South Australia, Australia, 5112
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Keswick, South Australia, Australia, 5035
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7510605
Status
Study Complete
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
Completed
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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