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" as compared to placebo.

Condition	Intervention	Phase
Dyslipidaemia	Drug: GW501516 oral tablets	Phase II

Further Study Details: 

Primary Outcomes: The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
Secondary Outcomes: 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.
Expected Total Enrollment:  424

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Exclusion criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00158899

Argentina
      GSK Clinical Trials Call Center, Leipzig,  O4107,  Argentina; Not yet recruiting
Belgium
      GSK Clinical Trials Call Center, LIEGE,  4000,  Belgium; Not yet recruiting
      GSK Clinical Trials Call Center, Brussels,  1200,  Belgium; Not yet recruiting
      GSK Clinical Trials Call Center, Edegem,  2650,  Belgium; Not yet recruiting
Denmark
      GSK Clinical Trials Call Center, Hellerup,  2900,  Denmark; Recruiting
Estonia
      GSK Clinical Trials Call Center, Tallin,  1162,  Estonia; Recruiting
      GSK Clinical Trials Call Center, Tallin,  13419,  Estonia; Recruiting
      GSK Clinical Trials Call Center, Tartu,  51014,  Estonia; Recruiting
Finland
      GSK Clinical Trials Call Center, Tampere,  7822,  Finland; Recruiting
      GSK Clinical Trials Call Center, Kuopio,  70210,  Finland; Recruiting
France
      GSK Clinical Trials Call Center, Caen-Cedex,  4 14052,  France; Recruiting
      GSK Clinical Trials Call Center, Lagord,  17140,  France; Recruiting
      GSK Clinical Trials Call Center, Creteil,  94010,  France; Recruiting
      GSK Clinical Trials Call Center, Toulouse,  31300,  France; Recruiting
Germany
      GSK Clinical Trials Call Center, Hamburg,  20249,  Germany; Terminated
      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
      GSK Clinical Trials Call Center, Goch,  47574,  Germany; Terminated
      GSK Clinical Trials Call Center, Schmiedeberg,  O1762,  Germany; Recruiting
      GSK Clinical Trials Call Center, Leipzig,  O4103,  Germany; Recruiting
      GSK Clinical Trials Call Center, Leipzig,  O4229,  Germany; Recruiting
      GSK Clinical Trials Call Center, Hamburg,  22525,  Germany; Recruiting
      GSK Clinical Trials Call Center, Gelnhausen,  63571,  Germany; Recruiting
      GSK Clinical Trials Call Center, Mainz,  55116,  Germany; Recruiting
      GSK Clinical Trials Call Center, Viersen,  41749,  Germany; Terminated
      GSK Clinical Trials Call Center, Leipzig,  04315,  Germany; Recruiting
      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
      GSK Clinical Trials Call Center, Hamburg,  20246,  Germany; Recruiting
      GSK Clinical Trials Call Center, Beckum,  59269,  Germany; Terminated
Lithuania
      GSK Clinical Trials Call Center, Vilnius,  LT-08661,  Lithuania; Recruiting
      GSK Clinical Trials Call Center, Vilnius,  LT-08314,  Lithuania; Recruiting
      GSK Clinical Trials Call Center, Kaunas,  LT-50009,  Lithuania; Recruiting
Netherlands
      GSK Clinical Trials Call Center, Rotterdam,  3045 PM,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Utrecht,  2584 CX,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Nijverdal,  7442 LS,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Rijswijk,  2281 AK,  Netherlands; Recruiting
Norway
      GSK Clinical Trials Call Center, Olso,  N-0160,  Norway; Recruiting
      GSK Clinical Trials Call Center, Oslo,  0319,  Norway; Recruiting
      GSK Clinical Trials Call Center, Oslo,  0176,  Norway; Recruiting
      GSK Clinical Trials Call Center, Fredrikstad,  1607,  Norway; Recruiting
      GSK Clinical Trials Call Center, Stavanger,  N-4011,  Norway; Recruiting
      GSK Clinical Trials Call Center, Oslo,  0103,  Norway; Terminated
      GSK Clinical Trials Call Center, Elverum,  2408,  Norway; Recruiting
      GSK Clinical Trials Call Center, Hamar,  2317,  Norway; Recruiting
      GSK Clinical Trials Call Center, Hamar,  N-2317,  Norway; Recruiting
      GSK Clinical Trials Call Center, Soerumsand,  N-1920,  Norway; Recruiting
Poland
      GSK Clinical Trials Call Center, Poznan,  61-848,  Poland; Recruiting
      GSK Clinical Trials Call Center, Krakow,  31-066,  Poland; Terminated
      GSK Clinical Trials Call Center, Warszawa,  00-685,  Poland; Recruiting
      GSK Clinical Trials Call Center, Olsztyn,  10-642,  Poland; Terminated
      GSK Clinical Trials Call Center, Warszawa,  02-097,  Poland; Recruiting
Portugal
      GSK Clinical Trials Call Center, Coimbra,  3000-075,  Portugal; Recruiting
      GSK Clinical Trials Call Center, Lisboa,  1169-024,  Portugal; Recruiting
      GSK Clinical Trials Call Center, Lisboa,  1649-035,  Portugal; Recruiting
Sweden
      GSK Clinical Trials Call Center, MALMO,  SE-205 02,  Sweden; Terminated

Study chairs or principal investigators

GSK Clinical Trials, MA,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  PAD20001
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158899
Health Authority: Belgium: FPS of Public Health, Food Chain Security and Environment, Directorate-General for Medicinal Products
ClinicalTrials.gov processed this record on 2005-09-13