N/A
Completed N=3,391
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
Source: ClinicalTrials.gov NCT01053429 ↗Enrolled (actual)
3,391
Serious AEs
0.1%
Results posted
Jan 2011
Primary outcomePrimary: Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population — 190; 1125; 1325; 506 particpants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population |
190; 1125; 1325; 506; 156; 46 | — |
| PRIMARY Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population |
130; 815; 889; 320; 77; 21 | — |
| PRIMARY Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT |
368; 1026; 1361; 512; 71; 13 | — |
| PRIMARY Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP |
271; 751; 889; 299; 36; 8 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01053429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.