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A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

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NCT01053429

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients diagnosed with schizophrenia

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who have known hypersensitivity to any ingredient of the product

- Patients who have had a recent acute myocardial infarction

- Patients who have uncompensated heart failure

- Patients who have conditions with a potential to increase QT interval (QT-interval
prolongation or history of QT prolongation; congenital long QT syndrome; use with
other drugs known to increase the QT interval; arrhythmias treated with class I and
III antiarrhythmic drugs)

NCT01053429
Pfizer
Completed
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule
This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.
All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.
  • Bipolar Disorder
  • Schizophrenia
Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
Other Name: Geodon, Zeldox
observational cohort
Intervention: Drug: ziprasidone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3391
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with schizophrenia

Exclusion Criteria:

  • Patients who have known hypersensitivity to any ingredient of the product
  • Patients who have had a recent acute myocardial infarction
  • Patients who have uncompensated heart failure
  • Patients who have conditions with a potential to increase QT interval (QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; arrhythmias treated with class I and III antiarrhythmic drugs)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01053429
A1281140
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

ClinicalT[email protected]



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