Trials / Completed
CompletedNCT04716595
A Phase III Long Term Study of K-877 Extended Release Tablet
A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Kowa Company, Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | K-877 ER 0.2 mg/day morning administration (once daily) | K-877 ER 0.2 mg tablet |
| DRUG | K-877 ER 0.2 mg/day evening administration (once daily) | K-877 ER 0.2 mg tablet |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2022-06-13
- Completion
- 2022-06-13
- First posted
- 2021-01-20
- Last updated
- 2025-11-24
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04716595. Inclusion in this directory is not an endorsement.