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Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 9, 2005
Last updated: October 18, 2012
Last verified: October 2012
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.

Condition Intervention Phase
Dyslipidaemias Drug: GW590735 Drug: fenofibrate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: November 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Drug: GW590735
1µg to 20µg daily doses of GW590735
Drug: fenofibrate
Marketed Drug
Active Comparator: Arm 2
Drug: GW590735
1µg to 20µg daily doses of GW590735

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00169559

  Show 50 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00169559     History of Changes
Other Study ID Numbers: PAA20001
Study First Received: September 9, 2005
Last Updated: October 18, 2012

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on September 21, 2017