Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- Esperion Therapeutics, Inc.
- Study ID
- NCT03067441
- Phase
- PHASE3
- Status
- Completed
Conditions
- Atherosclerotic Cardiovascular Disease
- Hypercholesterolemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bempedoic acid — DRUGbempedoic acid 180 mg tablets taken orally, once per day.
Study Details
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.
Key Dates
- Start date
- Feb 3, 2017
- Status verified
- Feb 2021
- Primary completion
- Nov 5, 2019
- Completion
- Nov 5, 2019
Study Design
- Enrollment
- 1,462 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-Label bempedoic acidbempedoic acid 180 mg tablet
Primary Outcome Measure
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 82 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jedidiah Clinical Research | Tampa | Florida | 33607 | - |
| L-MARC Research Center | Louisville | Kentucky | 40213 | - |
| Sentral Clinical Research Services | Cincinnati | Ohio | 45236 | - |
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