Status:
COMPLETED
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or ...
Eligibility Criteria
Inclusion
- Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety
Exclusion
- Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00265330
Start Date
March 1 2006
End Date
January 1 2008
Last Update
March 25 2021
Active Locations (41)
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1
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
2
Pfizer Investigational Site
San Diego, California, United States, 92123
3
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
4
Pfizer Investigational Site
Altamonte Springs, Florida, United States, 32701