Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

October 18, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E 7C5
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • GSK Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7V 2T8
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1V 4M6
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85014
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Healdsburg, California, United States, 95448
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Florida
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Ft Lauderale, Florida, United States, 33308
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
    • Illinois
      • Orland Park, Illinois, United States, 60462
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
    • New York
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
      • Williamsville, New York, United States, 14221
        • GSK Investigational Site
    • North Carolina
      • Statesville, North Carolina, United States, 28677
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16506
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Conroe, Texas, United States, 77304
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAA20001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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