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

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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.


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
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