NCT00158899

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2004

Geographic Reach
11 countries

64 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

September 8, 2005

Last Update Submit

May 24, 2017

Conditions

DyslipidaemiasDyslipidaemia

Keywords

HDLchigh-density lipoproteinDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.

    12 Weeks

Secondary Outcomes (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.

    12 Weeks

Interventions

GW501516 oral tabletsDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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/ATPĂ‚ III) guidelines.
  • Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (64)

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Hellerup, 2900, Denmark

Location

GSK Investigational Site

Tallinn, 10614, Estonia

Location

GSK Investigational Site

Tallinn, 11312, Estonia

Location

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Kuopio, 70210, Finland

Location

GSK Investigational Site

Tampere, 33200, Finland

Location

GSK Investigational Site

Caen, 14052, France

Location

GSK Investigational Site

Créteil, 94000, France

Location

GSK Investigational Site

Gières, 38610, France

Location

GSK Investigational Site

Lagord, 17140, France

Location

GSK Investigational Site

Poitiers, 86000 cedex, France

Location

GSK Investigational Site

Toulouse, 31300, France

Location

GSK Investigational Site

Haag, Bavaria, 83527, Germany

Location

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany

Location

GSK Investigational Site

Gelnhausen, Hesse, 63571, Germany

Location

GSK Investigational Site

Koenigslutter, Lower Saxony, 38154, Germany

Location

GSK Investigational Site

Winsen/Lohe, Lower Saxony, 21423, Germany

Location

GSK Investigational Site

Beckum, North Rhine-Westphalia, 59269, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51069, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Viersen, North Rhine-Westphalia, 41749, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04107, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04229, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04315, Germany

Location

GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, 39326, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10559, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 12524, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Berlin, 13158, Germany

Location

GSK Investigational Site

Berlin, 13347, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Hamburg, 22525, Germany

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08314, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08661, Lithuania

Location

GSK Investigational Site

Almere Stad, 1311 RL, Netherlands

Location

GSK Investigational Site

Deurne, 5751 XJ, Netherlands

Location

GSK Investigational Site

Etten-Leur, 4872 LA, Netherlands

Location

GSK Investigational Site

Nijverdal, 7442 LS, Netherlands

Location

GSK Investigational Site

Rijswijk, 2281 AK, Netherlands

Location

GSK Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

GSK Investigational Site

Rotterdam, 3045 PM, Netherlands

Location

GSK Investigational Site

Soerendonk, 6027 RN, Netherlands

Location

GSK Investigational Site

The Hague, 2582 LJ, Netherlands

Location

GSK Investigational Site

Bekkestua, N-1357, Norway

Location

GSK Investigational Site

Fredrikstad, N-1601, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

GSK Investigational Site

Oslo, 0160, Norway

Location

GSK Investigational Site

Oslo, 0176, Norway

Location

GSK Investigational Site

Oslo, 0319, Norway

Location

GSK Investigational Site

Paradis, 5231, Norway

Location

GSK Investigational Site

Soerumsand, N-1920, Norway

Location

GSK Investigational Site

Stavanger, N-4011, Norway

Location

GSK Investigational Site

Coimbra, 3000-075, Portugal

Location

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

GW 501516

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • GSK Clinical Trials, MA

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

DE(27)FR(6)SE(1)LI(3)NL(9)PT(1)BE(2)DK(1)NO(9)ES(3)FI(2)