Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease; Hypercholesterolemia

Treatments: Drug: bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03067441

2016-004115-12 (EudraCT Number)

1002-050

Details and patient eligibility

About

The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Enrollment: 1,462 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully completed CLEAR Harmony (1002-040) parent study

Exclusion criteria

• Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
• Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,462 participants in 1 patient group

Open-Label bempedoic acid

Experimental group

Description:

bempedoic acid 180 mg tablet

Treatment:

Drug: bempedoic acid