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Trial record 1 of 1 for:    NCT01124877
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Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

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ClinicalTrials.gov Identifier: NCT01124877
Recruitment Status : Withdrawn
First Posted : May 17, 2010
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 14, 2010
First Posted Date  ICMJE May 17, 2010
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
  • Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26 ]
  • Change from baseline in Physical exam [ Time Frame: week 26 ]
  • Change from baseline in Clinical laboratory tests [ Time Frame: weeks 2, 6, 18,26 ]
  • Change from baseline in body weight, height, BMI, BMI z score, and waist circumference [ Time Frame: weeks 6, 26 ]
  • Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01124877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
  • Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: weeks 2, 6, 18, and 26 ]
  • Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) [ Time Frame: weeks 2, 6, 18, and 26 ]
  • Change from Baseline in Child Health Questionnaire [ Time Frame: weeks 6 and 26 ]
  • Change from Baseline in School Placement Questionnaire [ Time Frame: weeks 6 and 26 ]
  • Change from Baseline in CNS Vital Signs Cognitive Test Battery [ Time Frame: weeks 6 and 26 ]
  • Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item [ Time Frame: weeks 6 and 26 ]
  • Change from Baseline in Simpson-Angus Rating Scale (SARS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ]
  • Change from Baseline in Barnes Akathisia Rating Scale (BAS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ]
  • Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ]
  • Change from Baseline in Childrens Global Assessment Scales [ Time Frame: weeks 2, 6, 18, and 26 ]
  • Change from Baseline in Tanner Adolescent Pubertal Self-Assessment [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Official Title  ICMJE 26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Brief Summary The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
Detailed Description Not Provided
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 Bipolar Disorder
Intervention  ICMJE Drug: ziprasidone oral capsules
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
Other Name: Zeldox, Geodon
Study Arms  ICMJE Open
Intervention: Drug: ziprasidone oral capsules
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2010)
153
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subjects must have received study medication in Study A1281196.
  • In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.

Exclusion Criteria:

  • Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
  • Subjects who are judged by the investigator as being at imminent risk of suicide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01124877
Other Study ID Numbers  ICMJE A1281197
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 Center Pfizer
PRS Account Pfizer
Verification Date January 2013

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