Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

Dyslipidaemias Clinical Trial

Official title:

A Multi-center, Three-staged, Randomized, Parallel Group, Sequential, Double-blind, fenofibrate-and Placebo-controlled Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma HDLc and TG of Eight Weeks Treatment With 1µg to 20µg Daily Doses of GW590735 in Otherwise Healthy Subjects With Low HDLc, Mildly to Moderately Elevated TG, and Normal LDLc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169559
• Other study ID #: PAA20001
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: October 18, 2012
• Start date: November 2003
• Est. completion date: April 2005

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.

Description:

A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• High-density lipoprotein cholesterol less than or equal to 45 mg/dL.

• Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL.

• Women must be surgically sterile or postmenopausal.

Exclusion criteria:

• Heart disease

• Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemias
• Dyslipidemias

Intervention

Drug:
• GW590735
1µg to 20µg daily doses of GW590735
• fenofibrate
Marketed Drug

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Québec	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Winnipeg	Manitoba
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Brooklyn Center	Minnesota
United States	GSK Investigational Site	Bryan	Texas
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Conroe	Texas
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Ft Lauderale	Florida
United States	GSK Investigational Site	Healdsburg	California
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orland Park	Illinois
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Sioux Falls	South Dakota
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Williamsville	New York
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment		8 weeks	No
Secondary	changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein		8 weeks	No