Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | November 15, 2016 |
| End Date: | April 16, 2018 |
A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe
versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
Inclusion Criteria:
- Require lipid-modifying therapy for primary or secondary prevention of cardiovascular
disease
- Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary
prevention (history of HeFH and/or ASCVD)
- Be statin-intolerant (unable to tolerate 2 or more statins)
Exclusion Criteria:
- Total fasting triglyceride ≥500 mg/dL
- Renal dysfunction or nephrotic syndrome or history of nephritis
- Body Mass Index (BMI) ≥50 kg/m2
- Significant cardiovascular disease or cardiovascular event in the past 3 months
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