Dyslipidemia Study Investigating The Increase In "Good Cholesterol"
- Registration Number
- NCT00169559
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.
- Detailed Description
A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 fenofibrate Placebo Arm 1 GW590735 Placebo Arm 2 GW590735 Fenofibrate
- Primary Outcome Measures
Name Time Method change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment 8 weeks
- Secondary Outcome Measures
Name Time Method changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein 8 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇦Sainte-Foy, Quebec, Canada
GSK Investigational Site🇨🇦Sainte-Foy, Quebec, Canada