Status:
COMPLETED
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dyslipidaemias
Dyslipidaemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00158899
Start Date
August 1 2004
End Date
June 1 2006
Last Update
May 30 2017
Active Locations (64)
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1
GSK Investigational Site
Brussels, Belgium, 1200
2
GSK Investigational Site
Liège, Belgium, 4000
3
GSK Investigational Site
Hellerup, Denmark, 2900
4
GSK Investigational Site
Tallinn, Estonia, 10614