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Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Psychotic Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ziprasidone versus olanzapine , risperidone or quetiapine
Panss , CGI-C, UKU-SERS-Pa
Blood tests
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV). Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator Exclusion Criteria: A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

PANSS (The Positive And Negative Syndrome Scale) in a 12 week period

Secondary Outcome Measures

CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight

Full Information

First Posted
September 8, 2005
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00159770
Brief Title
Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients
Official Title
Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - A 12-Week Open-Label, Multicenter Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ziprasidone versus olanzapine , risperidone or quetiapine
Intervention Type
Behavioral
Intervention Name(s)
Panss , CGI-C, UKU-SERS-Pa
Intervention Type
Procedure
Intervention Name(s)
Blood tests
Primary Outcome Measure Information:
Title
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Secondary Outcome Measure Information:
Title
CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV). Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator Exclusion Criteria: A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients
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
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Augustenborg
ZIP/Postal Code
6440
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Brovst
ZIP/Postal Code
9460
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Dianalund
ZIP/Postal Code
4293
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Esbjerg N
ZIP/Postal Code
6715
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Haderslev
ZIP/Postal Code
6100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kjellerup
ZIP/Postal Code
8620
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kobenhavn S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Lemvig
ZIP/Postal Code
7620
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Ringkobing
ZIP/Postal Code
6950
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Risskov
ZIP/Postal Code
8240
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Vordingborg
ZIP/Postal Code
4760
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Forssa
ZIP/Postal Code
30101
Country
Finland
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00099
Country
Finland
Facility Name
Pfizer Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kiviranta
ZIP/Postal Code
95410
Country
Finland
Facility Name
Pfizer Investigational Site
City
Mikkeli
ZIP/Postal Code
50520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20700
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tuusula
ZIP/Postal Code
04301
Country
Finland
Facility Name
Pfizer Investigational Site
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
Pfizer Investigational Site
City
Bern 60
State/Province
BE
ZIP/Postal Code
CH-3000
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
State/Province
BS
ZIP/Postal Code
CH-4025
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
St. Gallen
State/Province
SG
ZIP/Postal Code
9000
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lausanne
State/Province
VD
ZIP/Postal Code
1003
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Prangins
State/Province
VD
ZIP/Postal Code
1197
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zurich
State/Province
ZH
ZIP/Postal Code
8029
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bulle
ZIP/Postal Code
CH - 1630
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Chene-bourg
ZIP/Postal Code
1225
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Delemont
ZIP/Postal Code
CH-2800
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Oetwil
ZIP/Postal Code
CH-8618
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Riehen
ZIP/Postal Code
4125
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Saint Urban
ZIP/Postal Code
4915
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Solothurn
ZIP/Postal Code
CH-4503
Country
Switzerland

12. IPD Sharing Statement

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Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

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