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)