Last updated: 11/04/2018 10:11:30
Dyslipidemia Study Investigating The Increase In "Good Cholesterol"
GSK study ID
PAA20001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
Timeframe: 8 weeks
Secondary outcomes:
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
Timeframe: 8 weeks
Interventions:
Enrollment:
250
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dyslipidaemias
Product
GW590735
Collaborators
Not applicable
Study date(s)
November 2003 to March 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Heart disease
- Diabetes
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Orland Park, Illinois, United States, 60462
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Healdsburg, California, United States, 95448
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57105
Status
Study Complete
Location
GSK Investigational Site
Ft Lauderale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28677
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35243
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40213
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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