Status:
TERMINATED
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
13-17 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 adolescents (ages 13-17) with schizophrenia.
Detailed Description
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies we...
Eligibility Criteria
Inclusion
- Participation in double-blind treatment study A1281134, 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 A1281134
- Significant prolongation of QT interval in study A1281134
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00265382
Start Date
June 1 2006
End Date
June 1 2009
Last Update
March 3 2021
Active Locations (68)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-4400
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
4
Pfizer Investigational Site
San Diego, California, United States, 92123-2717