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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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 4, 2014
Last verified: June 2014

June 6, 2012
June 4, 2014
August 2012
February 2016   (final data collection date for primary outcome measure)
Change from baseline in PANSS total score [ Time Frame: Change from baseline ] [ Designated as safety issue: No ]
Change from baseline in PANSS total score [ Time Frame: Change from baseline ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01614912 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: SM-13496
40 or 80 mg once daily orally
Experimental: SM-13496
Intervention: Drug: SM-13496
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
435
Not Provided
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact: Dainippon Sumitomo Pharma Co., Ltd. Japan cc@ds-pharma.co.jp
Japan,   Korea, Republic of,   Malaysia,   Taiwan
 
NCT01614912
D1001057
No
Dainippon Sumitomo Pharma
Dainippon Sumitomo Pharma
Not Provided
Not Provided
Dainippon Sumitomo Pharma
June 2014

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