NCT00158899

GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dyslipidaemias
• Dyslipidaemia

Interventions

Type	Name	Description
DRUG	GW501516 oral tablets

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-09-12
• Last updated: 2017-05-30

Locations

64 sites across 11 countries: Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Netherlands, Norway, Portugal, Sweden