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

This study is currently recruiting participants.
Verified June 2012 by Dainippon Sumitomo Pharma
Sponsor:
Information provided by (Responsible Party):
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT01614912
First received: June 6, 2012
Last updated: November 21, 2013
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: SM-13496
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

Resource links provided by NLM:


Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Change from baseline in PANSS total score [ Time Frame: Change from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 435
Study Start Date: August 2012
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SM-13496 Drug: SM-13496
40 or 80 mg once daily orally

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614912

Contacts
Contact: Dainippon Sumitomo Pharma Co., Ltd. Japan cc@ds-pharma.co.jp

Locations
Japan
55 Sites Recruiting
Tokyo, etc, Japan
Principal Investigator: Doctor Site         
Korea, Republic of
14 Sites Recruiting
Seoul, etc, Korea, Republic of
Principal Investigator: Doctor Site         
Taiwan
12Sites Recruiting
Taipei, etc, Taiwan
Principal Investigator: Doctor Site         
Sponsors and Collaborators
Dainippon Sumitomo Pharma
  More Information

No publications provided

Responsible Party: Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier: NCT01614912     History of Changes
Other Study ID Numbers: D1001057
Study First Received: June 6, 2012
Last Updated: November 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014