NCT00265382

Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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 were stopped due to lack of efficacy. No safety concerns were identified.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Ziprasidone oral capsules	Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2005-12-14
• Last updated: 2021-03-03
• Results posted: 2010-05-19

Locations

68 sites across 9 countries: United States, Colombia, Costa Rica, India, Malaysia, Peru, Russia, Singapore, Ukraine