CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 344 enrolled
Drug / intervention
Ziprasidonedrug
Likely dose
20–80 mg orally twice dailyAI-extracted
Key inclusion· 3
  • ✓Successfully completed a previous ziprasidone clinical study
  • ✓Not currently hospitalized in an acute psychiatric service
  • ✓Written informed consent provided
Key exclusion· 13
  • ✕At immediate risk of harming self or others
  • ✕Requiring concurrent non-study antipsychotic agents
  • ✕Requiring antidepressants or mood stabilizers
  • ✕History of significant hematological, renal, hepatic, gastrointestinal, endocrine (except adequately treated thyroid disease), pulmonary, dermatological, oncological, or neurological disease (excluding tardive dyskinesia); any epilepsy form; prior malignancy except cured non-melanoma skin cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00139737
NCT00139737Phase 3Completed
CompareCT.gov

Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Aug 31, 2005·Updated Mar 3, 2021

In Brief

A Phase 3 clinical trial evaluating Ziprasidone for Schizophrenia. Completed, enrolled 344 participants across 87 sites.

Detailed Summary

To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2005
Enrollment StartMar 1, 2002
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.8 years ago

Interventions

Ziprasidonedrug

20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.