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

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ClinicalTrials.gov Identifier: NCT01053429
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : January 7, 2011
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Pfizer

January 19, 2010
January 21, 2010
December 21, 2010
January 7, 2011
January 7, 2011
June 2005
February 2010   (Final data collection date for primary outcome measure)
  • Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population [ Time Frame: Baseline up to Week 8 ]
    CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.
  • Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population [ Time Frame: Baseline up to Week 8 ]
    CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.
  • Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT [ Time Frame: Baseline up to Week 8 ]
    CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
  • Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP [ Time Frame: Baseline up to Week 8 ]
    CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Incidence of adverse event categorized according to physical organ and disease/ symptom and abnormal finding from laboratory test (if any) [ Time Frame: at each visit until the study ends approx. Apr 2010 ]
Complete list of historical versions of study NCT01053429 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinical Global Impression - Severity [ Time Frame: at each visit, baseline to final visit (8 weeks) (study ends approx. Apr 2010) ]
  • Clinical Global Impression - Improvement [ Time Frame: change from baseline at each visit until the study ends approx. Apr 2010) ]
  • Optional: Brief Psychiatric Rating Scale (BPRS ) or Drug Attitude Inventory (DAI-10) - Improvement [ Time Frame: at each visit until the study ends approx. Apr 2010 ]
Not Provided
Not Provided
 
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
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Bipolar Disorder
  • Schizophrenia
Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
Other Name: Geodon, Zeldox
observational cohort
Intervention: Drug: ziprasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3391
3400
February 2010
February 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01053429
A1281140
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010