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Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00265382
Pfizer
Terminated
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

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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
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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
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.
Other Name: Geodon, Zeldox
Open
Intervention: Drug: Ziprasidone oral capsules
Findling RL, Cavu? I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):531-44. doi: 10.1089/cap.2012.0068. Epub 2013 Oct 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
221
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   Costa Rica,   India,   Malaysia,   Peru,   Russian Federation,   Singapore,   Ukraine,   United States
Canada,   Germany,   Sweden
 
NCT00265382
A1281135
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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