Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Dyslipidaemias

Treatments: Drug: fenofibrate; Drug: GW590735

Study type: Interventional

Funder types: Industry

Identifiers

NCT00169559

PAA20001

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: fenofibrate

Drug: GW590735

Arm 2

Active Comparator group

Description:

Fenofibrate

Treatment:

Drug: GW590735