A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/31/2019 |
| Start Date: | December 2010 |
| End Date: | October 2011 |
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.
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.
ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
Major Inclusion Criteria:
- 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 Criteria:
- Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- Females of child bearing potential (i.e., females who are not surgically sterile or
post-menopausal)
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