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Clozapine

Phase 4FDA approved

Schizophrenia | Small molecule | Psychiatry |Viatris Inc.|Trials Updated: Feb 21, 2021

Clozapine development status

FDA approval on record Feb 10, 2004 as Fazaclo Odt
Approval holderJazz
ApplicationNDA021590
Highest phase Phase 4 run by Tirat Carmel Mental Health Center (NCT01663077)
Phase scored for VTRSPhase 3
Registered trials 9 across 6 sponsors since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Clozapine clinical trials

Clozapine · 1 trial · 1 indication

Phase 3 1
NCT00649844A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic DrugsSchizophrenia
COMPLETED147 Analytics
PHASE3COMPLETED
A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
Until Final Visit (within 18 weeks)

Secondary Endpoints

Proportion of responders, based on change from baseline to endpoint in PANSS total score
Until Final Visit (within 18 weeks)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
Baseline and weekly from Weeks 1-18
Time to discontinuation
Up to 18 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BEXPERIMENTAL -

Interventions

NameTypeDescription
ClozapineDRUGClozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks
ZiprasidoneDRUGZiprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * CGI - S ≥4 * PANSS ≥ 80 * Inpatients or outpatients Exclusion Criteria: * Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug * Diagnosis of substance dependence within previous 3 months using DSM-IV criteria * H...

Countries:Italy
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