Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | January 18, 2016 |
| End Date: | March 28, 2018 |
A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated
versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is
not adequately controlled by their current therapy.
versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is
not adequately controlled by their current therapy.
Inclusion Criteria:
- Fasting LDL-C ≥ 70 mg/dL
- High cardiovascular risk (diagnosis of HeFH 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
We found this trial at
46
sites
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