A Study Comparing the Safety and Efficacy of Ziprasidone... | NCT00645515

Studies
A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

NCT00645515

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Status

Terminated

Last Update Posted

Feb 21, 2021Actual

Enrollment

240Estimated

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Ziprasidone
Risperidone

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Dec 2003Actual

First Submitted Date

Mar 20, 2008

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental		Drug: Ziprasidone
Arm B	Active Comparator		Drug: Risperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ziprasidone	Drug	Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24		Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in cognitive function assessment at Weeks 4 and 24		Day 1 and Weeks 4 and 24
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24		Day 1 and Weeks 4, 10, 12, 16, and 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of schizophrenia
CGI-S score of 4 or less at baseline

Exclusion Criteria:

Concurrent antipsychotic treatment
Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
Acute exacerbation of schizophrenia within 3 months of baseline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Bilbao	Vizcaya	48010	Spain
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds