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

June 6, 2012
June 30, 2015
June 2012
November 2014   (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 NCT01614899 on ClinicalTrials.gov Archive Site
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A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: SM-13496 40mg
    once daily orally
  • Drug: SM-13496 80mg
    once daily orally
  • Drug: Placebo
    once daily orally
  • Experimental: SM-13496 40mg
    Intervention: Drug: SM-13496 40mg
  • Experimental: SM-13496 80mg
    Intervention: Drug: SM-13496 80mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
457
Not Provided
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Malaysia,   Taiwan
 
NCT01614899
D1001056, JapicCTI-121859
No
Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
Not Provided
Study Director: Clinical Development Drug development Division Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
June 2015

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