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A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Risperidone
Ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized patients with schizophrenia
  • Miminum PANSS score of 60 when randomized

Exclusion Criteria:

  • Planned, regular use of antipsyhotics within 1 week of randomization
  • Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Secondary Outcome Measures

Adverse events, laboratory test changes, movement disorder scale scores
Change from baseline in PANSS negative subscale score
Change from baseline in PANSS general psychopathology subscale score
PANSS responder rate
Clinical Global Impression-Severity (CGI-S) score
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Change from baseline in PANSS positive subscale score
Clinical Global Impression-Improement (CGI-I) score

Full Information

First Posted
March 24, 2008
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
NCT00645372
Brief Title
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
Official Title
A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Adverse events, laboratory test changes, movement disorder scale scores
Time Frame
Weeks 1, 2, 4, and 6
Title
Change from baseline in PANSS negative subscale score
Time Frame
Weeks 1, 2, 4, and 6
Title
Change from baseline in PANSS general psychopathology subscale score
Time Frame
Weeks 1, 2, 4, and 6
Title
PANSS responder rate
Time Frame
Weeks 1, 2, 4 and 6
Title
Clinical Global Impression-Severity (CGI-S) score
Time Frame
Baseline and Weeks 1, 2, 4, and 6
Title
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Time Frame
Weeks 1, 2, 4, and 6
Title
Change from baseline in PANSS positive subscale score
Time Frame
Weeks 1, 2, 4, and 6
Title
Clinical Global Impression-Improement (CGI-I) score
Time Frame
Weeks 1, 2, 4, and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients with schizophrenia Miminum PANSS score of 60 when randomized Exclusion Criteria: Planned, regular use of antipsyhotics within 1 week of randomization Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
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
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Pfizer Investigational Site
City
Guangzhou
ZIP/Postal Code
510370
Country
China
Facility Name
Pfizer Investigational Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281115&StudyName=A%20study%20to%20compare%20the%20efficacy%20and%20safety%20of%20ziprasidone%20and%20risperidone%20for%20the%20treatment%20of%20schizophrenia%20in%20Chinese%20patients
Description
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A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

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