A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
NCT ID: NCT01651273
Last Updated: 2013-08-05
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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TERMINATED
PHASE1
97 participants
INTERVENTIONAL
2012-11-30
2013-06-30
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
DOUBLE
Study Groups
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Arm 1: BMS-852927 (0.25 mg)
BMS-852927
Capsules, Oral, 0.25 mg, Once daily, 28 days
Arm 2: BMS-852927 (1.0 mg)
BMS-852927
Capsules, Oral, 1.0 mg, Once daily, 28 days
Arm 3: BMS-852927 (2.5 mg)
BMS-852927
Capsules, Oral, 2.5 mg, Once daily, 28 days
Arm 4: Placebo
Placebo
Capsules, Oral, 0 mg, Once daily, 28 days
Interventions
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BMS-852927
Capsules, Oral, 0.25 mg, Once daily, 28 days
BMS-852927
Capsules, Oral, 1.0 mg, Once daily, 28 days
BMS-852927
Capsules, Oral, 2.5 mg, Once daily, 28 days
Placebo
Capsules, Oral, 0 mg, Once daily, 28 days
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤ 40 kg/m2
* Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
* Serum triglyceride levels at screening \< 400mg/dL (\< 4.52 mmol/L)
Exclusion Criteria
* Current or history of hepatic or hepatobiliary disease
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
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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Local Institution
Brampton, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Pointe-Claire, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Victoriaville, Quebec, Canada
Local Institution
Berlin, , Germany
Local Institution
Neuss, , Germany
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2012-001946-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV201-008
Identifier Type: -
Identifier Source: org_study_id