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

Viatris

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder

Treatments: Drug: ziprasidone

Study type: Observational

Funder types: Industry

Identifiers

NCT01053429

A1281140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,391 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

3,391 participants in 1 patient group

observational cohort

Treatment:

Drug: ziprasidone