Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: SM-13496

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614912

JapicCTI-121860 (Registry Identifier)

D1001057

Details and patient eligibility

About

The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.

Enrollment: 284 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are considered by the investigator eligible for the present study with no significant safety concerns
• Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion criteria

• Patients who are planning pregnancy for the expected duration of the study
• Patients who are otherwise considered ineligible for the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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284 participants in 1 patient group

SM-13496

Experimental group

Treatment:

Drug: SM-13496