At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 43 enrolled
Drug / intervention
Ziprasidonedrug
Likely dose
Ziprasidone 40-80 mg orally twice daily (adjusted at protocol visits)AI-extracted
Key inclusion· 2
- ✓Successful completion of prior ziprasidone study (A1281031 or ZIP-NY-98035) with CGI score of 1 or 2 at final visit
- ✓QTc interval ≤500 msec
Key exclusion· 1
- ✕Patients not meeting the inclusion criteria
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 15, 2005·Updated Mar 24, 2021
In Brief
A Phase 3 clinical trial evaluating Ziprasidone for Schizophrenia. Completed, enrolled 43 participants across 14 sites.
Detailed Summary
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2001
First PostedSep 2005
Primary CompletionOct 2008
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartOct 1, 2001
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 20.8 years ago
Interventions
Ziprasidonedrug
Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid