Trials / Completed
CompletedNCT01053429
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,391 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ziprasidone | This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor. |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2010-01-21
- Last updated
- 2021-03-03
- Results posted
- 2011-01-07
Source: ClinicalTrials.gov record NCT01053429. Inclusion in this directory is not an endorsement.