Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Viatris

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Ziprasidone oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265382

A1281135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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221 participants in 1 patient group

Open

Other group

Treatment:

Drug: Ziprasidone oral capsules