A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
NCT01053429
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- Patients diagnosed with schizophrenia
- 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)
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Descriptive Information | ||||
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Brief Title | A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule | |||
Official Title | Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 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. | |||
Condition |
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Intervention | Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor. Other Name: Geodon, Zeldox | |||
Study Groups/Cohorts | observational cohort
Intervention: Drug: ziprasidone | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 3391 | |||
Original Estimated Enrollment | 3400 | |||
Actual Study Completion Date | February 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01053429 | |||
Other Study ID Numbers | A1281140 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | December 2010 |