NCT00169559

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_2

Geographic Reach
2 countries

50 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

1.4 years

First QC Date

September 9, 2005

Last Update Submit

October 18, 2012

Conditions

Dyslipidaemias

Keywords

triglyceridesHypertriglyceridemiacholesterolLDLHDL

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

  • 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

    8 weeks

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

Placebo

Drug: GW590735Drug: fenofibrate

Arm 2

ACTIVE COMPARATOR

Fenofibrate

Drug: GW590735

Interventions

GW590735DRUG

1µg to 20µg daily doses of GW590735

Arm 1Arm 2
fenofibrateDRUG

Marketed Drug

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Heart disease
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

GSK Investigational Site

Birmingham, Alabama, 35243, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85014, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85050, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85251, United States

Location

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

Healdsburg, California, 95448, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Spring Valley, California, 91978, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Fort Lauderale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33145, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Hollywood, Florida, 33021, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32205, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

GSK Investigational Site

Orland Park, Illinois, 60462, United States

Location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46260, United States

Location

GSK Investigational Site

Iowa City, Iowa, 52242, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40213, United States

Location

GSK Investigational Site

Auburn, Maine, 04210, United States

Location

GSK Investigational Site

Brooklyn Center, Minnesota, 55430, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

Endwell, New York, 13760, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Williamsville, New York, 14221, United States

Location

GSK Investigational Site

Statesville, North Carolina, 28677, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28412, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45219, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45246, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18102, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16506, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57105, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Kingsport, Tennessee, 37660, United States

Location

GSK Investigational Site

Bryan, Texas, 77802, United States

Location

GSK Investigational Site

Conroe, Texas, 77304, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Calgary, Alberta, T2E 7C5, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Laval, Quebec, H7V 2T8, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4M6, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

2-methyl-2-(4-(((4-methyl-2-(4-trifluoromethylphenyl)-thiazol-5-ylcarbonyl)amino)methyl)phenoxy)propionic acidFenofibrate

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(45)CA(5)