Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

NCT ID: NCT00169559

Last Updated: 2012-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-04-30

Brief Summary

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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

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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

Conditions

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Dyslipidaemias

Keywords

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triglycerides Hypertriglyceridemia cholesterol LDL HDL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Placebo

Group Type PLACEBO_COMPARATOR

GW590735

Intervention Type DRUG

1µg to 20µg daily doses of GW590735

fenofibrate

Intervention Type DRUG

Marketed Drug

Arm 2

Fenofibrate

Group Type ACTIVE_COMPARATOR

GW590735

Intervention Type DRUG

1µg to 20µg daily doses of GW590735

Interventions

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GW590735

1µg to 20µg daily doses of GW590735

Intervention Type DRUG

fenofibrate

Marketed Drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Beverly Hills, California, United States

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Healdsburg, California, United States

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Orange, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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DeLand, Florida, United States

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Fort Lauderale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Pembroke Pines, Florida, United States

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Orland Park, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Auburn, Maine, United States

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Brooklyn Center, Minnesota, United States

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Omaha, Nebraska, United States

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Endwell, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Williamsville, New York, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Allentown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Bryan, Texas, United States

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Conroe, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Laval, Quebec, Canada

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Québec, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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PAA20001

Identifier Type: -

Identifier Source: org_study_id