Trials / Completed
CompletedNCT01914393
Pediatric Open-Label Extension Study
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 702 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurasidone 20, 40, 60, 80 mg, flexibly dosed | Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed |
Timeline
- Start date
- 2013-09-30
- Primary completion
- 2018-10-17
- Completion
- 2018-10-17
- First posted
- 2013-08-02
- Last updated
- 2019-12-19
- Results posted
- 2019-12-19
Locations
88 sites across 15 countries: United States, Bulgaria, Colombia, France, Hungary, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Ukraine
Source: ClinicalTrials.gov record NCT01914393. Inclusion in this directory is not an endorsement.