GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
Phase 2
Completed
- Conditions
- DyslipidaemiasDyslipidaemia
- Registration Number
- NCT00158899
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.
- Detailed Description
A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 424
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. 12 Weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516. 12 Weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇸🇪Malmö, Sweden