Trials / Completed
CompletedNCT05683340
A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 180mg of ETC-1002(bempedoic acid) | 180mg, tablet, once daily, for 12 weeks |
| DRUG | Placebo | placebo, tablet, once daily, for 12 weeks |
Timeline
- Start date
- 2023-02-13
- Primary completion
- 2024-02-20
- Completion
- 2024-03-12
- First posted
- 2023-01-13
- Last updated
- 2025-03-13
- Results posted
- 2025-03-13
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05683340. Inclusion in this directory is not an endorsement.