Dyslipidemia Study Investigating The Increase In "Good Cholesterol" - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169559

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia Hypertriglyceridemia	Drug: GW590735 Drug: fenofibrate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Procetofen GW 590735

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment

Secondary Outcome Measures:

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

Estimated Enrollment:	250
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169559

Show 33 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00169559 History of Changes
Other Study ID Numbers:	PAA20001
Study First Received:	September 9, 2005
Last Updated:	September 12, 2005
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

HDL
triglycerides
LDL
cholesterol

Additional relevant MeSH terms:

Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012