We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 64 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials, MA GlaxoSmithKline
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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:
HDLc
high-density lipoprotein
Dyslipidemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases