Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)

Phase 4

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00418171
• Lead Sponsor: Pfizer

Brief Summary

The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Study First Posted: 2007-01-04
• Study Completion: 2007-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-23
• Last Update Posted: 2009-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18239

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.

Secondary Outcome Measures

Name	Time	Method
To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause mortality, mortality due to suicide, cardiovascular mortality, mortality due to sudden death	During the year observation period
To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis	During the year observation period
The rate of discontinuation of randomized treatment.	During the year observation period

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Whitehall, West Virginia, United States