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

This study is not yet open for participant recruitment.

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: June 21, 2012

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:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lurasidone Lurasidone hydrochloride

U.S. FDA Resources

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

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

Locations

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:	June 21, 2012
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 June 17, 2013