FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey
Launched by AZUR PHARMA, INC · May 23, 2008
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with treatment-resistant schizophrenia currently being treated with Clozaril or generic clozapine for at least 3 months
- • Patients with treatment-resistant schizophrenia who failed to respond adequately to treatment with at least 2 courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs
- • Males and females of 18 years of age or older
- • Females of childbearing potential using a reliable form of contraception
- • Ability to comply with the required WBC/ANC monitoring schedule
- • Ability to follow physician's instructions
- • Signed informed consent by patient or legal guardian
- Exclusion Criteria:
- • Phenylketonurics
- • Females of childbearing potential not using a reliable form of contraception
- • Women who are pregnant or want to become pregnant
- • Nursing
- • Patients allergic to clozapine or any othe ingredient contained in FazaClo tablets
- • Patients who have previously experienced a severe adverse reaction to clozapine
- • Patients previously excluded from taking clozapine due to a higher risk of developing white blood cell disorders
- • Clinical significant medical condition that the physician believes may increase the patient's risk of participating int he study (e.g., severe cardiac disorder, epilepsy)
- • Concomitant medications that may be contraindicated with FazaClo
- • Patients who have been taking FazaCLo within the last three months
- • Patients unable to comply with the required WBC/ANC monitoring schedule
- • Patients unable to follow the physician's instructions
- • Patients unable or unwilling to provide Informed Consent
About Azur Pharma, Inc
Azur Pharma, Inc. is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies that address unmet medical needs across a range of therapeutic areas. With a focus on advancing patient care, Azur Pharma leverages cutting-edge research and development methodologies to bring novel treatments to market. The company is committed to maintaining the highest standards of clinical trial integrity and regulatory compliance, ensuring that its products are both safe and effective. By fostering strategic partnerships and collaborations, Azur Pharma aims to enhance the quality of life for patients worldwide through groundbreaking medical solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Costa Mesa, California, United States
Gastonia, North Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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