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 |
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.
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
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