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A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

Summary

Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia. This study is not recruiting in the United States.

Clinical Details

Official title: A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Values of hematological tests during the 24 week treatment

Incidence of hematological adverse events during the 24 week treatment

Compliance to Clozapine Patient Monitoring System during the 24 week treatment

Secondary outcome:

Changes in the symptoms of psychosis every 4 weeks up to week 24

Global change in severity of psychosis at baseline and week 12

Global impression of change in the condition of patients at week 12 and 24

Detailed description: Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed as schizophrenia

- Not responded to at least two atypical antipshychotics launched in Japan

- Inpatient

Exclusion Criteria:

- Low white blood cell count

- Significant heart diseases

- Diabetes mellitus

Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Novartis Investigational Site, Chiba, Japan

Novartis Investigative Site, Fukuoka, Japan

Novartis Investigative Site, Ishikawa, Japan

Novartis Investigative Site, Osaka, Japan

Novartis Investigative Site, Saga, Japan

Novartis Investigative Site, Tokyo, Japan

Novartis Investigative Site, Toyama, Japan

Novartis Investigative Site, Yamanashi, Japan

Additional Information

Starting date: November 2005
Last updated: May 3, 2012

Page last updated: August 20, 2015

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