12 Week Open, Non-Comparative Switch Study Of Oral Zipraz... | NCT00159757

Studies
12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

NCT00159757

Sponsor

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

Status

Terminated

Last Update Posted

Feb 21, 2021Actual

Enrollment

150

Phase

Phase 4

Conditions

Schizophrenia

Interventions

ziprazidone

Countries

Hungary

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

See Detailed Description for Termination Reason

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 12, 2005Estimated

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

Description Module

Brief Summary

There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.

Detailed Description

Study was terminated due to difficulty in enrolling the targeted number of patients on March 1, 2005, last subject last visit date was Feb.16, 2005. There were no safety concerns involved in the decision to terminate the trial.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
ziprazidone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
Safety- Incidence and severity of the side effects

Secondary Outcomes

Measure	Description	Time Frame
To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)
To evaluate the influence on the body weight change.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files
subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria:

patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)
in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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		Budapest			Hungary
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C092292	ziprasidone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided