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Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

GlaxoSmithKline (GSK) logo

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

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

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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