Trials / Completed
CompletedNCT02666664
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,230 (actual)
- Sponsor
- Esperion Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ETC-1002 | ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided) |
| DRUG | Placebo | Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided) |
Timeline
- Start date
- 2016-01-21
- Primary completion
- 2018-02-21
- Completion
- 2018-03-28
- First posted
- 2016-01-28
- Last updated
- 2020-05-11
- Results posted
- 2020-04-20
Locations
104 sites across 6 countries: United States, Canada, Germany, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02666664. Inclusion in this directory is not an endorsement.