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

Primary Purpose

Dyslipidaemias, Dyslipidaemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW501516 oral tablets
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidaemias focused on measuring HDLc, high-density lipoprotein, Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2005
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00158899
Brief Title
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemias, Dyslipidaemia
Keywords
HDLc, high-density lipoprotein, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW501516 oral tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MA
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
GSK Investigational Site
City
Caen cedex 4
ZIP/Postal Code
14052
Country
France
Facility Name
GSK Investigational Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
GSK Investigational Site
City
Gières
ZIP/Postal Code
38610
Country
France
Facility Name
GSK Investigational Site
City
Lagord
ZIP/Postal Code
17140
Country
France
Facility Name
GSK Investigational Site
City
Poitiers
ZIP/Postal Code
86000 cedex
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
GSK Investigational Site
City
Haag
State/Province
Bayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
GSK Investigational Site
City
Hoehenkirchen-Siegertsbrunn
State/Province
Bayern
ZIP/Postal Code
85635
Country
Germany
Facility Name
GSK Investigational Site
City
Gelnhausen
State/Province
Hessen
ZIP/Postal Code
63571
Country
Germany
Facility Name
GSK Investigational Site
City
Koenigslutter
State/Province
Niedersachsen
ZIP/Postal Code
38154
Country
Germany
Facility Name
GSK Investigational Site
City
Winsen/Lohe
State/Province
Niedersachsen
ZIP/Postal Code
21423
Country
Germany
Facility Name
GSK Investigational Site
City
Beckum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59269
Country
Germany
Facility Name
GSK Investigational Site
City
Goch
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47574
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Viersen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41749
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
GSK Investigational Site
City
Wolmirstedt
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39326
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04107
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04229
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04315
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12524
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13158
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22525
Country
Germany
Facility Name
GSK Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08314
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
GSK Investigational Site
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2582 LJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Deurne
ZIP/Postal Code
5751 XJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Etten-leur
ZIP/Postal Code
4872 LA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rijswijk
ZIP/Postal Code
2281 AK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Roelofarendsveen
ZIP/Postal Code
2371 RB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Soerendonk
ZIP/Postal Code
6027 RN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bekkestua
ZIP/Postal Code
N-1357
Country
Norway
Facility Name
GSK Investigational Site
City
Fredrikstad
ZIP/Postal Code
N-1601
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0160
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0176
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
GSK Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
GSK Investigational Site
City
Soerumsand
ZIP/Postal Code
N-1920
Country
Norway
Facility Name
GSK Investigational Site
City
Stavanger
ZIP/Postal Code
N-4011
Country
Norway
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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