Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

NCT00265382

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
Official Title  ICMJE 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
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 were stopped due to lack of efficacy. No safety concerns were identified.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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
Study Arms  ICMJE Open
Intervention: Drug: Ziprasidone oral capsules
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 16, 2010)
221
Original Enrollment  ICMJE
 (submitted: December 12, 2005)
180
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Costa Rica,   India,   Malaysia,   Peru,   Russian Federation,   Singapore,   Ukraine,   United States
Removed Location Countries Canada,   Germany,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT00265382
Other Study ID Numbers  ICMJE A1281135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP