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

Sponsor:	GlaxoSmithKline
Information provided by (Responsible Party):	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
Dyslipidaemias	Drug: GW590735 Drug: fenofibrate	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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

Drug Information available for: Fenofibrate

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	250
Study Start Date:	November 2003
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Arm 1 Placebo	Drug: GW590735 1µg to 20µg daily doses of GW590735 Drug: fenofibrate Marketed Drug
Active Comparator: Arm 2 Fenofibrate	Drug: GW590735 1µg to 20µg daily doses of GW590735

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

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 48 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169559 History of Changes
Other Study ID Numbers:	PAA20001
Study First Received:	September 9, 2005
Last Updated:	April 12, 2012
Health Authority:	Canada: Health Canada United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

triglycerides
Hypertriglyceridemia
cholesterol
LDL
HDL

Additional relevant MeSH terms:

Dyslipidemias
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 May 24, 2012