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

Condition(s) targeted: Schizophrenia

Intervention: Ziprasidone (Drug); Olanzapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Primary outcome: 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:

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

To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis

The rate of discontinuation of randomized treatment.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Pfizer Investigational Site, Whitehall, West Virginia, United States

To obtain contact information for a study center near you, click here.

Starting date: February 2002
Ending date: April 2007
Last updated: March 25, 2008