GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol

• ClinicalTrials.gov Identifier: NCT00158899
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: May 30, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: September 8, 2005
• First Posted Date: September 12, 2005
• Last Update Posted Date: May 30, 2017
• Study Start Date: August 2004
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 14, 2007): The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. [ Time Frame: 12 Weeks ]
• Original Primary Outcome Measures (submitted: September 8, 2005): The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
• Current Secondary Outcome Measures (submitted: August 14, 2007): 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. [ Time Frame: 12 Weeks ]
• Original Secondary Outcome Measures (submitted: September 8, 2005): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
• 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)
• 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 and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.
• 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 cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Dyslipidaemias
• Dyslipidaemia

• Intervention: Drug: GW501516 oral tablets
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2005): 424
• Original Enrollment: Same as current
• Actual Study Completion Date: June 2006
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Netherlands, Norway, Portugal, Sweden
• Removed Location Countries: Argentina, Poland

Administrative Information

• NCT Number: NCT00158899
• Other Study ID Numbers: PAD20001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Not Provided
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials, MA; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: May 2017