Clinical trial NCT00169559: Dyslipidemia Study Investigating The Increase In "Good Cholesterol"
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidaemias
Keywords: triglycerides
Hypertriglyceridemia
cholesterol
LDL
HDL
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Healdsburg
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Ft Lauderale
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Orland Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Brooklyn Center
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Williamsville
country: United States
facility: GSK Investigational Site
state: New York
city: Statesville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bryan
country: United States
facility: GSK Investigational Site
state: Texas
city: Conroe
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Laval
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: