Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
NCT ID: NCT01112423
Last Updated: 2015-10-12
Study Results
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-823778 (2 mg)
BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
BMS-823778 (10 mg)
BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
BMS-823778 (20 mg)
BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
Placebo
Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Interventions
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BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Eligibility Criteria
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Inclusion Criteria
* Currently taking a stable daily dose of statin therapy
* Serum triglyceride level \< 500mg/dl
Exclusion Criteria
* Congestive heart failure
* Diabetes mellitus
* Active liver disease
* Impaired renal function
* Hepatitis C, B and HIV
This list is not inclusive; additional information is provided in the protocol
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Osborne Research Center
Little Rock, Arkansas, United States
Pra International
Lenexa, Kansas, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States
Cetero Research - San Antonio
San Antonio, Texas, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Local Institution
Brisbane, Queensland, Australia
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Mount Pearl, Newfoundland and Labrador, Canada
Local Institution
London, Ontario, Canada
Local Institution
Drummondville, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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MB121-003
Identifier Type: -
Identifier Source: org_study_id
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