Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
Overview
- Phase
- Phase 3
- Intervention
- Ziprasidone
- Conditions
- Schizophrenia
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc \<= 500 msec.
Exclusion Criteria
- •All other patients who do not fit the inclusion criteria as stated above.
Arms & Interventions
A1
Intervention: Ziprasidone
Outcomes
Primary Outcomes
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Change From Baseline in CGI-I at End of Study (up to 5 Years)
Time Frame: Baseline, up to 5 years (End of Study [LOCF])
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Change From Baseline in CGI-S at End of Study (up to 5 Years)
Time Frame: Baseline, up to 5 years (End of Study [LOCF])
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
Secondary Outcomes
- Number of Participants With Scores on Patient Preference Scale (PPS)(Baseline, up to 5 years (End of Study))
- Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)(Baseline, up to 5 years (End of Study))