Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/14/2018 |
| Start Date: | November 18, 2016 |
| End Date: | September 25, 2018 |
A Long-term, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk Not Adequately Controlled by Their Lipid-Modifying Therapy
The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo
in patients with high cardiovascular risk and elevated LDL cholesterol not adequately
controlled by their current therapy.
in patients with high cardiovascular risk and elevated LDL cholesterol not adequately
controlled by their current therapy.
Inclusion Criteria:
- Fasting LDL-C ≥100 mg/dL
- High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
- Be on maximally tolerated lipid-modifying therapy
Exclusion Criteria:
- Total fasting triglyceride ≥500 mg/dL
- Renal dysfunction or nephrotic syndrome or history of nephritis
- Body Mass Index (BMI) ≥50kg/m2
- Significant cardiovascular disease or cardiovascular event in the past 3 months
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