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Clinical Trials List

Protocol NumberD1001057
NCT Number(ClinicalTrials.gov Identfier)NCT01614912

2012-09-01 - 2016-02-28

Phase III

Terminated8

ICD-10F20.9

Schizophrenia, unspecified

Long-term Extension Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Dainippon Sumitomo Pharma Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chin-Bin Yeh Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林式穀 Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 梁珪瑜 Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator mei feng Huang Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 周勵志 Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林清華 Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ya-Mei Bai Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tzung-Jeng Hwang Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Terminated

Condition/Disease

Schizophrenia

Objectives

The study objective is to evaluate the long-term safety and efficacy of SM-13496 (40 or 80 mg/day) in patients with schizophrenia.

Test Drug

SM-13496

Active Ingredient

Lurasidone HCl

Dosage Form

Tablet

Dosage

40 mg、80mg

Endpoints

Safety will be assessed by the proportion of subjects with Adverse Events (AEs), Discontinuations due to AEs, and Serious Adverse Events (SAEs).
Secondary efficacy measures will be assessed by the Change from baseline in the PANSS total score by subscales etc.

Inclution Criteria

Main InExclusion 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

Exclusion criteria
- Patients who are planning pregnancy for the expected duration of the study

The Estimated Number of Participants

  • Taiwan

    340 participants

  • Global

    435 participants