Status:
COMPLETED
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
Eligibility Criteria
Inclusion
- Male or female Chinese subjects aged 18-65 years (including 65) at screening.
- Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X).
- Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days
Exclusion
- History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.
- Subjects receiving an investigational agent in the previous 3 months prior to screening.
- Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00723606
Start Date
September 1 2008
End Date
July 1 2009
Last Update
March 3 2021
Active Locations (9)
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1
Pfizer Investigational Site
Baoding, Hebei, China, 071000
2
Pfizer Investigational Site
Wuhan, Hubei, China, 430060
3
Pfizer Investigational Site
Kunming, Yunnan, China, 650032
4
Pfizer Investigational Site
Beijing, China, 100083