Status:
COMPLETED
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Lead Sponsor:
Esperion Therapeutics, Inc.
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
Eligibility Criteria
Inclusion
- Major
- Provision of written informed consent prior to any study-specific procedure
- Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
- Fasting triglyceride \<400 mg/dL following wash-out of all lipid regulating medications and supplements
- BMI between 18 and 35 mg/kg2
- Major
Exclusion
- Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2011
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01262638
Start Date
December 1 2010
End Date
August 23 2011
Last Update
March 17 2021
Active Locations (11)
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1
Chandler, Arizona, United States, 85225
2
Greenbrae, California, United States, 94904
3
Santa Rosa, California, United States, 95405
4
Jacksonville, Florida, United States, 32216