Clinical Trial: A Study To Examine The Effect And Safety Of GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol (Also Known as "Good Cholesterol")

A Study To Examine The Effect And Safety Of GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol (Also Known as "Good Cholesterol")

This study is currently recruiting patients.
Verified by GlaxoSmithKline August 2005

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158899

Purpose

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

MedlinePlus related topics:  Metabolic Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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

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

Study start: August 2004

Eligibility

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158899


Argentina
      GSK Clinical Trials Call Center, Leipzig,  O4107,  Argentina; Not yet recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Belgium
      GSK Clinical Trials Call Center, LIEGE,  4000,  Belgium; Not yet recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Brussels,  1200,  Belgium; Not yet recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Edegem,  2650,  Belgium; Not yet recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Denmark
      GSK Clinical Trials Call Center, Hellerup,  2900,  Denmark; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Estonia
      GSK Clinical Trials Call Center, Tallin,  1162,  Estonia; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Tallin,  13419,  Estonia; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Tartu,  51014,  Estonia; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Finland
      GSK Clinical Trials Call Center, Tampere,  7822,  Finland; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Kuopio,  70210,  Finland; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

France
      GSK Clinical Trials Call Center, Caen-Cedex,  4 14052,  France; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Lagord,  17140,  France; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Creteil,  94010,  France; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Toulouse,  31300,  France; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Germany
      GSK Clinical Trials Call Center, Hamburg,  20249,  Germany; Terminated

      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Goch,  47574,  Germany; Terminated

      GSK Clinical Trials Call Center, Schmiedeberg,  O1762,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Leipzig,  O4103,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Leipzig,  O4229,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Hamburg,  22525,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Gelnhausen,  63571,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Mainz,  55116,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Viersen,  41749,  Germany; Terminated

      GSK Clinical Trials Call Center, Leipzig,  04315,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Berlin,  13125,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Hamburg,  20246,  Germany; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      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  1-877-379-3718 

      GSK Clinical Trials Call Center, Vilnius,  LT-08314,  Lithuania; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Kaunas,  LT-50009,  Lithuania; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Netherlands
      GSK Clinical Trials Call Center, Rotterdam,  3045 PM,  Netherlands; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Utrecht,  2584 CX,  Netherlands; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Nijverdal,  7442 LS,  Netherlands; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Rijswijk,  2281 AK,  Netherlands; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Norway
      GSK Clinical Trials Call Center, Olso,  N-0160,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Oslo,  0319,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Oslo,  0176,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Fredrikstad,  1607,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Stavanger,  N-4011,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Oslo,  0103,  Norway; Terminated

      GSK Clinical Trials Call Center, Elverum,  2408,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Hamar,  2317,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Hamar,  N-2317,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Soerumsand,  N-1920,  Norway; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Poland
      GSK Clinical Trials Call Center, Poznan,  61-848,  Poland; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      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  1-877-379-3718 

      GSK Clinical Trials Call Center, Olsztyn,  10-642,  Poland; Terminated

      GSK Clinical Trials Call Center, Warszawa,  02-097,  Poland; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Portugal
      GSK Clinical Trials Call Center, Coimbra,  3000-075,  Portugal; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Lisboa,  1169-024,  Portugal; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

      GSK Clinical Trials Call Center, Lisboa,  1649-035,  Portugal; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718 

Sweden
      GSK Clinical Trials Call Center, MALMO,  SE-205 02,  Sweden; Terminated

Study chairs or principal investigators

GSK Clinical Trials, MA,  Study Director,  GlaxoSmithKline   

More Information

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

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