Trials / Completed
CompletedNCT03465787
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (actual)
- Sponsor
- Bukwang Pharmaceutical · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurasidone HCL 160 mg | Lurasidone HCL 2 80mg tablets, QD |
| DRUG | Quetiapine XR 600 mg | Quetiapine XR 2 300 mg tablets, QD |
Timeline
- Start date
- 2018-04-09
- Primary completion
- 2022-10-26
- Completion
- 2022-10-26
- First posted
- 2018-03-14
- Last updated
- 2023-02-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03465787. Inclusion in this directory is not an endorsement.