A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
NCT01053429
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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)
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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:
| |||
| Sex/Gender |
| |||
| 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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2021 | |||