An Open-Label Study Changing Generic Clozapine Formulation to FazaClo® (Clozapine, USP) Orally Disintegrating Tablets in Stable Patients With Schizophrenia or Schizoaffective Disorder
Sponsor study identifier
interventional
20
1 country
2
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Study Completion
July 2009
Actual (reported)The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2007
Actual (reported)July 16, 2007
Actual (reported)March 2009
Actual (reported)July 2009
Actual (reported)To determine the equivalence of generic clozapine tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are already taking generic clozapine and are switched to FazaClo.
14 days
Whether side effects are comparable when equivalent plasma levels are present
14 days
Whether clinical efficacy is maintained after the switch to Fazaclo
14 days
open label switch from generic clozapine to Fazaclo
single-arm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Manhattan Psychiatric Center, 125th Street, Out Patient Clinic
New York, New York, 10027, United States
Manhattan Psychiatric Center, Inpatient Unit
New York, New York, 10035, United States
Jean-Pierre Lindenmayer, MD
Manhattan Psychiatric Center
Saurabh Kaushik, MD
Nathan Kline Institute & Manhattan Psychiatric Center
20 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2007
First Posted
July 16, 2007
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
April 15, 2015
Record last verified: 2015-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: