Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

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NCT00174447

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Study Location
Pfizer Investigational Site
Avignon, , 84000, France
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Contact
1-800-718-1021
[email protected]
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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- All other patients who do not fit the inclusion criteria as stated above.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Official Title  ICMJE Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
Brief Summary Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
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 Schizophrenia
Intervention  ICMJE Drug: Ziprasidone
Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid
Study Arms  ICMJE Experimental: A1
Intervention: Drug: Ziprasidone
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2007)		43
Original Enrollment  ICMJE
 (submitted: September 12, 2005)		120
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion Criteria:

  • All other patients who do not fit the inclusion criteria as stated above.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174447
Other Study ID Numbers  ICMJE A1281060
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021

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