Last updated: 11/04/2018 10:11:54
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
GSK study ID
PAD20001
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
Timeframe: 12 Weeks
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.
Timeframe: 12 Weeks
Interventions:
Drug: GW501516 oral tablets
Enrollment:
424
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dyslipidaemias
Product
GW501516
Collaborators
Not applicable
Study date(s)
August 2004 to June 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- 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).
- Coronary heart disease.
- Diabetes mellitus.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
Status
Study Complete
Location
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41749
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
Status
Study Complete
Location
GSK Investigational Site
Koenigslutter, Niedersachsen, Germany, 38154
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
ROELOFARENDSVEEN, Netherlands, 2371 RB
Status
Study Complete
Location
GSK Investigational Site
Winsen/Lohe, Niedersachsen, Germany, 21423
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-20-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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