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Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174447
First received: September 12, 2005
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone


Condition Intervention Phase
Schizophrenia
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] ] [ Designated as safety issue: No ]
  • Change From Baseline in CGI-I at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study [LOCF]) ] [ Designated as safety issue: No ]
  • Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] ] [ Designated as safety issue: No ]
  • Change From Baseline in CGI-S at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study [LOCF]) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Scores on Patient Preference Scale (PPS) [ Time Frame: Baseline, up to 5 years (End of Study) ] [ Designated as safety issue: No ]
  • Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study) ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: October 2001
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Ziprasidone
Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion Criteria:

  • All other patients who do not fit the inclusion criteria as stated above.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174447

Locations
France
Pfizer Investigational Site
Avignon, France, 84000
Pfizer Investigational Site
Dole Saint Ylie, France, 39108
Pfizer Investigational Site
Lievin, France, 62800
Pfizer Investigational Site
Lyon Cedex, France, 69373
Pfizer Investigational Site
Montfavet, France, 84143
Pfizer Investigational Site
Orvault, France, 44700
Pfizer Investigational Site
Rennes, France, 35000
Pfizer Investigational Site
Saint Egreve Cedex, France, 38521
Pfizer Investigational Site
Saint Remy, France, 70160
Pfizer Investigational Site
Strasbourg, France, 67100
Pfizer Investigational Site
Toulon Cedex, France, 83056
Pfizer Investigational Site
Toulouse, France, 31200
Pfizer Investigational Site
Toulouse, France, 31000
Pfizer Investigational Site
Versailles, France, 78000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00174447     History of Changes
Other Study ID Numbers: A1281060
Study First Received: September 12, 2005
Results First Received: October 15, 2009
Last Updated: November 20, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014