Back to resultsLarge Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00418171
Brief Title
Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
Official Title
An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18239 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
The rate of discontinuation of randomized treatment.
Time Frame
During the year observation period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
San Bernardino
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Aiea
State/Province
Hawaii
Country
United States
Facility Name
Pfizer Investigational Site
City
Schaumburg
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Grants Pass
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Whitehall
State/Province
West Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24717389
Citation
Fleischhacker WW, Kane JM, Geier J, Karayal O, Kolluri S, Eng SM, Reynolds RF, Strom BL. Completed and attempted suicides among 18,154 subjects with schizophrenia included in a large simple trial. J Clin Psychiatry. 2014 Mar;75(3):e184-90. doi: 10.4088/JCP.13m08563.
Results Reference
derived
PubMed Identifier
23246610
Citation
Kolitsopoulos FM, Strom BL, Faich G, Eng SM, Kane JM, Reynolds RF. Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia. Contemp Clin Trials. 2013 Mar;34(2):239-47. doi: 10.1016/j.cct.2012.12.001. Epub 2012 Dec 12.
Results Reference
derived
PubMed Identifier
21041245
Citation
Strom BL, Eng SM, Faich G, Reynolds RF, D'Agostino RB, Ruskin J, Kane JM. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry. 2011 Feb;168(2):193-201. doi: 10.1176/appi.ajp.2010.08040484. Epub 2010 Nov 1.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281062&StudyName=Large+Simple+Trial+%28LST%29+Of+Cardiovascular+Safety+Of+Ziprasidone+And+Olanzapine%2D+%28Zodiac%29%2E
Description
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Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
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