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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
1µg to 20µg daily doses of GW590735
Marketed Drug
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
Time frame: 8 weeks
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
Time frame: 8 weeks
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Healdsburg, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
Spring Valley, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
DeLand, Florida, United States
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