A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2004
Last Updated Date	April 9, 2009
Start Date ^ICMJE	July 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00088621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Official Title ^ICMJE	An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
Brief Summary	A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Detailed Description	Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group 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	Completed
Enrollment ^ICMJE	100
Completion Date	December 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either: Successfully completed OR Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
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	NCT00088621
Responsible Party
Study ID Numbers ^ICMJE	D1050199
Study Sponsor ^ICMJE	Sumitomo Pharmaceuticals America
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sumitomo Pharmaceuticals America
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP