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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00143351 |
To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of resistant schizophrenic subjects who have benefited from participation in the phase III ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of oral Ziprasidone
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Ziprasidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Extension Study Evaluating the Long-Term Efficacy, Safety, and Tolerability of Oral Ziprasidone in the Treatment of Resistant/Intolerant Schizophrenic Patients Who Have Acutely Responded to Ziprasidone in the Mozart Study |
Estimated Enrollment: | 75 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Pfizer Investigational Site | |
BRESCIA, Italy, 25100 | |
Pfizer Investigational Site | |
TRIESTE, Italy, 34126 | |
Pfizer Investigational Site | |
VERONA, Italy, 37100 | |
Pfizer Investigational Site | |
BARI, Italy, 70100 | |
Pfizer Investigational Site | |
SASSARI, Italy, 07100 | |
Pfizer Investigational Site | |
ROMA, Italy, 00135 | |
Pfizer Investigational Site | |
TORINO, Italy, 10126 | |
Pfizer Investigational Site | |
ROMA, Italy, 00100 | |
Pfizer Investigational Site | |
MESSINA, Italy, 98100 | |
Pfizer Investigational Site | |
PARMA, Italy, 43100 | |
Pfizer Investigational Site | |
TERNI, Italy | |
Pfizer Investigational Site | |
ROMA, Italy, 00137 | |
Pfizer Investigational Site | |
GUARDIAGRELE (CH), Italy, 66016 | |
Pfizer Investigational Site | |
Catania, Italy, 95123 | |
Italy, Bassano Del Grappa | |
Pfizer Investigational Site | |
VICENZA, Bassano Del Grappa, Italy, 36061 | |
Italy, PERUGIA | |
Pfizer Investigational Site | |
CITTA' DI CASTELLO, PERUGIA, Italy, 06012 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A1281088 |
Study First Received: | August 31, 2005 |
Last Updated: | December 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00143351 |
Health Authority: | Italy: Ministry of Health |
Schizophrenia Dopamine Mental Disorders Psychotic Disorders |
Ziprasidone Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |