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Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174447
First Posted: September 15, 2005
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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] ]
  • 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]) ]
  • 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] ]
  • 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]) ]

Secondary Outcome Measures:
  • Number of Participants With Scores on Patient Preference Scale (PPS) [ Time Frame: Baseline, up to 5 years (End of Study) ]
  • 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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 31000
Pfizer Investigational Site
Toulouse, France, 31200
Pfizer Investigational Site
Versailles, France, 78000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: October 15, 2009
Results First Posted: November 17, 2009
Last Update Posted: November 25, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents