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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
424
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
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GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Hellerup, Denmark
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Kuopio, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Caen, France
GSK Investigational Site
Créteil, France
...and 54 more locations