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GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00158899
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

Brief Summary:
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.

Condition or disease Intervention/treatment Phase
Dyslipidaemias Dyslipidaemia Drug: GW501516 oral tablets Phase 2

Detailed Description:
A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)
Study Start Date : August 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: GW 501516

Primary Outcome Measures :
  1. The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516. [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Have a fasting plasma HDLc concentration <=45mg/dL (<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines.
  • Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).

Exclusion criteria:

  • Coronary heart disease.
  • Diabetes mellitus.
  • Atherosclerotic disease.

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): NCT00158899

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MA GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158899    
Other Study ID Numbers: PAD20001
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
high-density lipoprotein
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases