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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW501516 oral tablets | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. | 12 Weeks |
| Measure | Description | 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. | 12 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MA | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
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| Liège |
| 4000 |
| Belgium |
| GSK Investigational Site | Hellerup | 2900 | Denmark |
| GSK Investigational Site | Tallinn | 10614 | Estonia |
| GSK Investigational Site | Tallinn | 11312 | Estonia |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Kuopio | 70210 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Caen | 14052 | France |
| GSK Investigational Site | Créteil | 94000 | France |
| GSK Investigational Site | Gières | 38610 | France |
| GSK Investigational Site | Lagord | 17140 | France |
| GSK Investigational Site | Poitiers | 86000 cedex | France |
| GSK Investigational Site | Toulouse | 31300 | France |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Höhenkirchen-Siegertsbrunn | Bavaria | 85635 | Germany |
| GSK Investigational Site | Gelnhausen | Hesse | 63571 | Germany |
| GSK Investigational Site | Koenigslutter | Lower Saxony | 38154 | Germany |
| GSK Investigational Site | Winsen/Lohe | Lower Saxony | 21423 | Germany |
| GSK Investigational Site | Beckum | North Rhine-Westphalia | 59269 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Viersen | North Rhine-Westphalia | 41749 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04107 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04229 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04315 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| GSK Investigational Site | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10559 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | 12524 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | 13158 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | Hamburg | 22525 | Germany |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08314 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08661 | Lithuania |
| GSK Investigational Site | Almere Stad | 1311 RL | Netherlands |
| GSK Investigational Site | Deurne | 5751 XJ | Netherlands |
| GSK Investigational Site | Etten-Leur | 4872 LA | Netherlands |
| GSK Investigational Site | Nijverdal | 7442 LS | Netherlands |
| GSK Investigational Site | Rijswijk | 2281 AK | Netherlands |
| GSK Investigational Site | Roelofarendsveen | 2371 RB | Netherlands |
| GSK Investigational Site | Rotterdam | 3045 PM | Netherlands |
| GSK Investigational Site | Soerendonk | 6027 RN | Netherlands |
| GSK Investigational Site | The Hague | 2582 LJ | Netherlands |
| GSK Investigational Site | Bekkestua | N-1357 | Norway |
| GSK Investigational Site | Fredrikstad | N-1601 | Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Oslo | 0160 | Norway |
| GSK Investigational Site | Oslo | 0176 | Norway |
| GSK Investigational Site | Oslo | 0319 | Norway |
| GSK Investigational Site | Paradis | 5231 | Norway |
| GSK Investigational Site | Soerumsand | N-1920 | Norway |
| GSK Investigational Site | Stavanger | N-4011 | Norway |
| GSK Investigational Site | Coimbra | 3000-075 | Portugal |
| GSK Investigational Site | Malmö | SE-205 02 | Sweden |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C425931 | GW 501516 |
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