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OpenTrials
Completed

NCT Number: NCT00418171

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, San Bernardino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

Olanzapine

Drug

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. The rate of discontinuation of randomized treatment.

    Time frame: During the year observation period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Jan 4, 2007
Registry last updated
Oct 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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