Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139737
First received: August 29, 2005
Last updated: August 2, 2010
Last verified: August 2010
Results First Received: June 15, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Ziprasidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This extension study enrolled eligible subjects with schizophrenia who had successfully completed a previous Phase 3 ziprasidone study (A1281028, A1281044 or A1281045 [NCT00136994]), allowing enrolled subjects to continue treatment with ziprasidone for at least 1 year or until the drug became commercially available.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ziprasidone Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.

Participant Flow:   Overall Study
    Ziprasidone  
STARTED     344  
Received Treatment     331  
COMPLETED     3  
NOT COMPLETED     341  
Withdrawal by Subject                 190  
Adverse Event                 58  
Lack of Efficacy                 40  
Lost to Follow-up                 8  
Death                 3  
Laboratory Abnormality                 2  
Protocol Violation                 18  
Withdrew During Screening Phase                 8  
Did Not Meet Entrance Criteria                 1  
Screened, Not Treated                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ziprasidone Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.

Baseline Measures
    Ziprasidone  
Number of Participants  
[units: participants]
  331  
Age, Customized  
[units: Participants]
 
18-44 years     238  
45-64 years     93  
Gender  
[units: Participants]
 
Female     138  
Male     193  



  Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 72 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00139737     History of Changes
Other Study ID Numbers: A1281061
Study First Received: August 29, 2005
Results First Received: June 15, 2010
Last Updated: August 2, 2010
Health Authority: Italy: Ministry of Health