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A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 424 |
| Start date | 2004-08 |
| Completion | 2006-06 |
Conditions
- Dyslipidaemias
- Dyslipidaemia
Interventions
- GW501516 oral tablets
Primary outcomes
- The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. — 12 Weeks
Countries
Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Netherlands, Norway, Portugal, Sweden