A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant
Phase of Trial: Phase III
Latest Information Update: 04 May 2017
At a glance
- Drugs Bempedoic acid (Primary)
- Indications Cardiovascular disorders; Hypercholesterolaemia
- Focus Therapeutic Use
- Acronyms CLEAR-Serenity; CVOT
- Sponsors Esperion Therapeutics
- 04 May 2017 According to an Esperion Therapeutics media release, the patient enrollment in this study will be completed in the second half of 2017.
- 20 Mar 2017 According to an Esperion Therapeutics media release, top-line results expected by mid-2018.
- 20 Mar 2017 According to an Esperion Therapeutics media release, company plans to submit a new drug application (NDA) by 1H 2019 based on the successful completion of the global pivotal Phase 3 program. The US FDA also confirmed that LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.