A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
NCT ID: NCT01779453
Last Updated: 2019-03-29
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
58 participants
INTERVENTIONAL
2012-12-31
2013-08-31
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
QUADRUPLE
Study Groups
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ETC-1002
ETC-1002 treatment group, oral once daily
ETC-1002
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Atorvastatin
Atorvastatin 10mg once daily for 8 weeks
Placebo
Placebo treatment group, oral once daily
Placebo
Placebo once daily for 8 weeks
Atorvastatin
Atorvastatin 10mg once daily for 8 weeks
Interventions
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ETC-1002
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Placebo
Placebo once daily for 8 weeks
Atorvastatin
Atorvastatin 10mg once daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL
Exclusion Criteria
* Uncontrolled hypertension
18 Years
80 Years
ALL
No
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Noah Rosenberg, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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1002-007
Identifier Type: -
Identifier Source: org_study_id
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