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Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

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ClinicalTrials.gov Identifier: NCT00169559
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Dyslipidaemias Drug: GW590735 Drug: fenofibrate Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Arm 1
Placebo
Drug: GW590735
1µg to 20µg daily doses of GW590735
Drug: fenofibrate
Marketed Drug
Active Comparator: Arm 2
Fenofibrate
Drug: GW590735
1µg to 20µg daily doses of GW590735



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169559


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169559     History of Changes
Other Study ID Numbers: PAA20001
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline:
triglycerides
Hypertriglyceridemia
cholesterol
LDL
HDL

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents