A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01053429
First received: January 19, 2010
Last updated: December 21, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder Schizophrenia |
Drug: ziprasidone |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 3391 |
| Study Start Date: | June 2005 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| observational cohort |
Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
Other Name: Geodon, Zeldox
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01053429 History of Changes |
| Other Study ID Numbers: | A1281140 |
| Study First Received: | January 19, 2010 |
| Results First Received: | December 21, 2010 |
| Last Updated: | December 21, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Pfizer:
|
Regulatory Post-Marketing Surveillance Regulatory Pharmacovigilance ziprasidone |
Additional relevant MeSH terms:
|
Bipolar Disorder Schizophrenia Affective Disorders, Psychotic Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Ziprasidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013