Overview

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

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Ziprasidone
Criteria
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)