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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 6, 2012

Last Updated Date

June 21, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

February 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from baseline in PANSS total score [ Time Frame: Change from baseline ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01614912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: SM-13496

40 or 80 mg once daily orally

Study Arm (s)

Experimental: SM-13496

Intervention: Drug: SM-13496

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

435

Completion Date

Not Provided

Estimated Primary Completion Date

February 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dainippon Sumitomo Pharma Co., Ltd. Japan

cc@ds-pharma.co.jp

Location Countries ^ICMJE

Japan, Korea, Republic of, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01614912

Other Study ID Numbers ^ICMJE

D1001057

Has Data Monitoring Committee

Responsible Party

Dainippon Sumitomo Pharma

Study Sponsor ^ICMJE

Dainippon Sumitomo Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Dainippon Sumitomo Pharma

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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