CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,391 enrolled
Drug / intervention
ziprasidonedrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Diagnosis of schizophrenia
Key exclusion· 4
  • ✕Known hypersensitivity to ziprasidone or any ingredient
  • ✕Recent acute myocardial infarction
  • ✕Uncompensated heart failure
  • ✕QT-interval prolongation risk: baseline prolongation, congenital long QT syndrome, concomitant QT-prolonging drugs, or arrhythmias treated with class I/III antiarrhythmics

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01053429
NCT01053429N/ACompleted
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Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Jan 21, 2010·Updated Mar 3, 2021

In Brief

An observational study evaluating ziprasidone for Bipolar Disorder and Schizophrenia. Completed, enrolled 3,391 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Schizophrenia
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2010
Enrollment StartJun 1, 2005
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.4 years ago

Interventions

ziprasidonedrug

This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.