Safety and Tolerability Study of Drug to Treat Schizophrenia - Tabular View

Tracking Information
First Received Date ^ICMJE	August 16, 2002
Last Updated Date	March 11, 2009
Start Date ^ICMJE	September 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: SM-13496
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	150
Completion Date	December 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria: Successful completion of participation in Sumitomo protocol #D1050049 Exclusion criteria: Substance abuse Prolactin level of ≥200ng/mL at baseline Pregnancy
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044005
Responsible Party
Study ID Numbers ^ICMJE	D1050174
Study Sponsor ^ICMJE	Sumitomo Pharmaceuticals America
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sumitomo Pharmaceuticals America
Verification Date	May 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP