Dyslipidemia Study Investigating The Increase In Good Cholesterol

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Dyslipidaemias

Intervention / Treatment
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* Drug: GW590735
* Drug: fenofibrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>Placebo | Drug: GW590735<br>* 1µg to 20µg daily doses of GW590735<br>Drug: fenofibrate<br>* Marketed Drug<br>|
| Active Comparator: Arm 2<br>Fenofibrate | Drug: GW590735<br>* 1µg to 20µg daily doses of GW590735<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triglycerides, Hypertriglyceridemia, cholesterol, LDL, HDL