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

May 24, 2017 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

424

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Denmark
      • Hellerup, Denmark, 2900
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tallinn, Estonia, 10614
        • GSK Investigational Site
      • Tallinn, Estonia, 11312
        • GSK Investigational Site
  • Finland
      • Kuopio, Finland, 70210
        • GSK Investigational Site
      • Tampere, Finland, 33200
        • GSK Investigational Site
  • France
      • Caen cedex 4, France, 14052
        • GSK Investigational Site
      • Créteil, France, 94000
        • GSK Investigational Site
      • Gières, France, 38610
        • GSK Investigational Site
      • Lagord, France, 17140
        • GSK Investigational Site
      • Poitiers, France, 86000 cedex
        • GSK Investigational Site
      • Toulouse, France, 31300
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 13347
        • GSK Investigational Site
      • Berlin, Germany, 10559
        • GSK Investigational Site
      • Berlin, Germany, 12524
        • GSK Investigational Site
      • Berlin, Germany, 13158
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 22525
        • GSK Investigational Site
    • Bayern
      • Haag, Bayern, Germany, 83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
        • GSK Investigational Site
    • Hessen
      • Gelnhausen, Hessen, Germany, 63571
        • GSK Investigational Site
    • Niedersachsen
      • Koenigslutter, Niedersachsen, Germany, 38154
        • GSK Investigational Site
      • Winsen/Lohe, Niedersachsen, Germany, 21423
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Beckum, Nordrhein-Westfalen, Germany, 59269
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Viersen, Nordrhein-Westfalen, Germany, 41749
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04107
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04229
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04315
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
      • Schmiedeberg, Sachsen, Germany, 01762
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • GSK Investigational Site
      • Wolmirstedt, Sachsen-Anhalt, Germany, 39326
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08314
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
  • Netherlands
      • Almere, Netherlands, 1311 RL
        • GSK Investigational Site
      • Den Haag, Netherlands, 2582 LJ
        • GSK Investigational Site
      • Deurne, Netherlands, 5751 XJ
        • GSK Investigational Site
      • Etten-leur, Netherlands, 4872 LA
        • GSK Investigational Site
      • Nijverdal, Netherlands, 7442 LS
        • GSK Investigational Site
      • Rijswijk, Netherlands, 2281 AK
        • GSK Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • GSK Investigational Site
      • Soerendonk, Netherlands, 6027 RN
        • GSK Investigational Site
  • Norway
      • Bekkestua, Norway, N-1357
        • GSK Investigational Site
      • Fredrikstad, Norway, N-1601
        • GSK Investigational Site
      • Hamar, Norway, 2317
        • GSK Investigational Site
      • Oslo, Norway, 0160
        • GSK Investigational Site
      • Oslo, Norway, 0176
        • GSK Investigational Site
      • Oslo, Norway, 0319
        • GSK Investigational Site
      • Paradis, Norway, 5231
        • GSK Investigational Site
      • Soerumsand, Norway, N-1920
        • GSK Investigational Site
      • Stavanger, Norway, N-4011
        • GSK Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
  • Sweden
      • Malmö, Sweden, SE-205 02
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, MA, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAD20001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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