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

Pfizer18,239 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

18,239

Conditions

Schizophrenia

Interventions

ZiprasidoneDRUG

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Pfizer Investigational Site

San Bernardino, California, United States

Pfizer Investigational Site

‘Aiea, Hawaii, United States

Pfizer Investigational Site

Schaumburg, Illinois, United States

Pfizer Investigational Site

Grants Pass, Oregon, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: 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

Time frame: During the year observation period

The rate of discontinuation of randomized treatment.

Time frame: During the year observation period

Data from ClinicalTrials.gov

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