Status:
COMPLETED
Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
Lead Sponsor:
Pfizer
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.
Eligibility Criteria
Inclusion
- Patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy.
- Male and female patients who meet all criteria listed below are eligible to be enrolled in this study:
- Diagnosed with schizophrenia
- Willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study
Exclusion
- Progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study
- Previously randomized to study medication and enrolled in this study
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
18239 Patients enrolled
Trial Details
Trial ID
NCT00418171
Start Date
February 1 2002
End Date
April 1 2007
Last Update
October 26 2009
Active Locations (5)
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1
Pfizer Investigational Site
San Bernardino, California, United States
2
Pfizer Investigational Site
‘Aiea, Hawaii, United States
3
Pfizer Investigational Site
Schaumburg, Illinois, United States
4
Pfizer Investigational Site
Grants Pass, Oregon, United States