Study In Patients With Dyslipidaemia
Phase 2
Completed
- Conditions
- Metabolic Syndrome X
- Registration Number
- NCT00264667
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Study in patients with dyslipidaemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
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.
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Exclusion Criteria
- History of diabetes
- History of cardiovascular disease
- Diagnosis of genetic lipid disorders
- History of muscle pain
- History of cancer
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
- Secondary Outcome Measures
Name Time Method Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Tarrasa, Barcelona, Spain