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

Dyslipidaemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158899
• Other study ID #: PAD20001
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 24, 2017
• Start date: August 2004
• Est. completion date: June 2006

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidaemias
• Dyslipidemias

Intervention

Drug:
• GW501516 oral tablets

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Liège
Denmark	GSK Investigational Site	Hellerup
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Caen cedex 4
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Gières
France	GSK Investigational Site	Lagord
France	GSK Investigational Site	Poitiers
France	GSK Investigational Site	Toulouse
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Gelnhausen	Hessen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koenigslutter	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Viersen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Winsen/Lohe	Niedersachsen
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Netherlands	GSK Investigational Site	Almere
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Deurne
Netherlands	GSK Investigational Site	Etten-leur
Netherlands	GSK Investigational Site	Nijverdal
Netherlands	GSK Investigational Site	Rijswijk
Netherlands	GSK Investigational Site	Roelofarendsveen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Soerendonk
Norway	GSK Investigational Site	Bekkestua
Norway	GSK Investigational Site	Fredrikstad
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Paradis
Norway	GSK Investigational Site	Soerumsand
Norway	GSK Investigational Site	Stavanger
Portugal	GSK Investigational Site	Coimbra
Sweden	GSK Investigational Site	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Denmark,  Estonia,  Finland,  France,  Germany,  Lithuania,  Netherlands,  Norway,  Portugal,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.		12 Weeks
Secondary	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.		12 Weeks