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Safety and Tolerability Study of Drug to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044005
Recruitment Status : Completed
First Posted : August 20, 2002
Results First Posted : May 19, 2011
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE August 16, 2002
First Posted Date  ICMJE August 20, 2002
Results First Submitted Date  ICMJE February 16, 2011
Results First Posted Date  ICMJE May 19, 2011
Last Update Posted Date April 17, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
Number of Participants With Adverse Events [ Time Frame: 6-months ]
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00044005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of Drug to Treat Schizophrenia
Official Title  ICMJE A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
Brief Summary The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Lurasidone 20 mg
    Lurasidone 20mg oral tablet taken once daily for 6-months
  • Drug: Lurasidone 40 mg
    Lurasidone 40mg oral tablets taken once daily
  • Drug: Lurasidone 80mg
    Lurasidone 80mg oral tablet taken once daily
Study Arms  ICMJE
  • Experimental: Lurasidone 20 mg
    Lurasidone 20 mg oral tablet
    Intervention: Drug: Lurasidone 20 mg
  • Experimental: Lurasidione 40 mg
    Lurasidone 40 mg oral tablet
    Intervention: Drug: Lurasidone 40 mg
  • Experimental: Lurasidone 80mg
    Lurasidone 80mg oral tablet
    Intervention: Drug: Lurasidone 80mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2011)
98
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
150
Actual Study Completion Date  ICMJE November 2003
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Successful completion of participation in protocol #D1050049

Exclusion criteria:

  • Substance abuse
  • Prolactin level of ≥200ng/mL at baseline
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044005
Other Study ID Numbers  ICMJE D1050174
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director, MD Sunovion
PRS Account Sunovion
Verification Date March 2014

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