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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Page 1 of 11 (41 locations)

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