A Study of the Efficacy and Safety of ETC-1002 in Subjects With Statin Intolerance



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/31/2019
Start Date:October 2012
End Date:May 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and a History of Statin Intolerance

This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in
subjects with hypercholesterolemia and a history of statin intolerance.


Key Inclusion Criteria:

- A history of statin intolerance that began during statin treatment and resolved within
4 weeks of stopping the statin treatment

- For subjects on current lipid-regulating drugs - LDL-C 100-220 mg/dL and triglycerides
<350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)

- For subjects not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting
TG <400 mg/dL

Key Exclusion Criteria:

- Acute significant cardiovascular disease

- Poorly controlled hypertension
We found this trial at
5
sites
Clinical Trial Facility in Wilmington North Carolina
Wilmington, North Carolina 28401
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Wilmington, NC
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Clinical Trial Facility in Hartford Connecticut
Hartford, Connecticut 06106
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Hartford, CT
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Knoxville Tennessee
Knoxville, Tennessee 37920
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Knoxville, TN
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Clinical Trial Facility in Raleigh North Carolina
Raleigh, North Carolina 27607
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Raleigh, NC
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