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

NCT ID: NCT00158899

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Dyslipidaemias Dyslipidaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW501516 oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MA

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Liège, , Belgium

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GSK Investigational Site

Hellerup, , Denmark

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GSK Investigational Site

Tallinn, , Estonia

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GSK Investigational Site

Tallinn, , Estonia

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GSK Investigational Site

Tallinn, , Estonia

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GSK Investigational Site

Kuopio, , Finland

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GSK Investigational Site

Tampere, , Finland

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GSK Investigational Site

Caen, , France

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GSK Investigational Site

Créteil, , France

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GSK Investigational Site

Gières, , France

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GSK Investigational Site

Lagord, , France

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GSK Investigational Site

Poitiers, , France

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GSK Investigational Site

Toulouse, , France

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GSK Investigational Site

Haag, Bavaria, Germany

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GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, Germany

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GSK Investigational Site

Gelnhausen, Hesse, Germany

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GSK Investigational Site

Koenigslutter, Lower Saxony, Germany

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GSK Investigational Site

Winsen/Lohe, Lower Saxony, Germany

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GSK Investigational Site

Beckum, North Rhine-Westphalia, Germany

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GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

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GSK Investigational Site

Viersen, North Rhine-Westphalia, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Schmiedeberg, Saxony, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

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GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

Kaunas, , Lithuania

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GSK Investigational Site

Vilnius, , Lithuania

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GSK Investigational Site

Vilnius, , Lithuania

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GSK Investigational Site

Almere Stad, , Netherlands

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GSK Investigational Site

Deurne, , Netherlands

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GSK Investigational Site

Etten-Leur, , Netherlands

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GSK Investigational Site

Nijverdal, , Netherlands

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GSK Investigational Site

Rijswijk, , Netherlands

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GSK Investigational Site

Roelofarendsveen, , Netherlands

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GSK Investigational Site

Rotterdam, , Netherlands

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GSK Investigational Site

Soerendonk, , Netherlands

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GSK Investigational Site

The Hague, , Netherlands

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GSK Investigational Site

Bekkestua, , Norway

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GSK Investigational Site

Fredrikstad, , Norway

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GSK Investigational Site

Hamar, , Norway

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GSK Investigational Site

Oslo, , Norway

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GSK Investigational Site

Oslo, , Norway

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GSK Investigational Site

Oslo, , Norway

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GSK Investigational Site

Paradis, , Norway

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GSK Investigational Site

Soerumsand, , Norway

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GSK Investigational Site

Stavanger, , Norway

Site Status

GSK Investigational Site

Coimbra, , Portugal

Site Status

GSK Investigational Site

Malmo, , Sweden

Site Status

Countries

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Belgium Denmark Estonia Finland France Germany Lithuania Netherlands Norway Portugal Sweden

Other Identifiers

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PAD20001

Identifier Type: -

Identifier Source: org_study_id

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