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Long-term Extension 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:
NCT01614912
First received: June 6, 2012
Last updated: June 30, 2015
Last verified: June 2015
  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:


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: 284
Study Start Date: August 2012
Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: NCT01614912

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
14Sites
Taipei, etc, Taiwan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
  More Information

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01614912     History of Changes
Other Study ID Numbers: D1001057  JapicCTI-121860 
Study First Received: June 6, 2012
Last Updated: June 30, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on December 02, 2016