Dyslipidaemias
Conditions
Keywords
triglycerides, Hypertriglyceridemia, cholesterol, LDL, HDL
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
Interventions
DRUGGW590735
1µg to 20µg daily doses of GW590735
DRUGfenofibrate
Marketed Drug
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High-density lipoprotein cholesterol less than or equal to 45 mg/dL. * Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL. * Women must be surgically sterile or postmenopausal.
Exclusion criteria
* Heart disease * Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed