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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
History of Changes

September 12, 2005
November 20, 2009
October 2001
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
Safety
Complete list of historical versions of study NCT00174447 on ClinicalTrials.gov Archive Site
  • 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 ]
CGI
Not Provided
Not Provided
 
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
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

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
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
Experimental: A1
Intervention: Drug: Ziprasidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00174447
A1281060
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP