A Phase III 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:
NCT01614899
First received: June 6, 2012
Last updated: November 21, 2013
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: SM-13496 40mg
Drug: SM-13496 80mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory 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: June 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SM-13496 40mg Drug: SM-13496 40mg
once daily orally
Experimental: SM-13496 80mg Drug: SM-13496 80mg
once daily orally
Placebo Comparator: Placebo Drug: Placebo
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:

  • Patient meets DSM-IV-TR criteria for schizophrenia.
  • Patient is aged 18 through 74 years at informed consent.
  • Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria:

  • Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
  • Patient has Parkinson's disease.
  • Patient has a history or complication of malignancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614899

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

Locations
Japan
55 Sites Recruiting
Tokyo, etc, Japan
Contact: See central contact details         
Principal Investigator: Docter Site         
Korea, Republic of
14 Sites Recruiting
Seoul, etc, Korea, Republic of
Contact: See central contact details         
Principal Investigator: Docter Site         
Taiwan
12 Sites Recruiting
Taipei, etc, Taiwan
Contact: See central contact details         
Principal Investigator: Doctor Site         
Sponsors and Collaborators
Dainippon Sumitomo Pharma
Investigators
Study Director: Clinical Development Drug development Division Dainippon Sumitomo Pharma
  More Information

No publications provided

Responsible Party: Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier: NCT01614899     History of Changes
Other Study ID Numbers: D1001056
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 22, 2014