A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01614899
First received: June 6, 2012
Last updated: June 30, 2015
Last verified: June 2015
  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 Sumitomo Dainippon Pharma Co., Ltd.:

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

Enrollment: 457
Study Start Date: June 2012
Primary Completion Date: November 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614899

Locations
Japan
69 Sites
Tokyo, etc, Japan
Korea, Republic of
22 Sites
Seoul, etc, Korea, Republic of
Malaysia
10 Sites
Kuala Lumpur, etc, Malaysia
Taiwan
14 Sites
Taipei, etc, Taiwan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
Study Director: Clinical Development Drug development Division Sumitomo Dainippon Pharma Co., Ltd.
  More Information

No publications provided

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01614899     History of Changes
Other Study ID Numbers: D1001056, JapicCTI-121859
Study First Received: June 6, 2012
Last Updated: June 30, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on August 02, 2015