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
- Inclusion criteria:
- High-density lipoprotein cholesterol less than or equal to 45 mg/dL.
Inclusion and exclusion criteria
Inclusion 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
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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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