A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Study ID
- NCT05687071
- Phase
- PHASE3
- Status
- Completed
Conditions
- Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- 180mg of ETC-1002(bempedoic acid) — DRUG180mg, tablet, once daily, for 52 weeks
Study Details
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
Key Dates
- Start date
- Feb 27, 2023
- Status verified
- Feb 2026
- Primary completion
- Oct 5, 2024
- Completion
- Nov 2, 2024
Study Design
- Enrollment
- 130 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ETC-1002 180mg
Primary Outcome Measure
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From baseline to week 52 ]