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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00174447 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
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Scientific title:
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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 |
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Date of first enrolment:
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October 2001 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00174447 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Ziprasidone
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Primary Outcome(s)
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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]]
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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]]
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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])]
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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])]
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Secondary Outcome(s)
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Number of Participants With Scores on Patient Preference Scale (PPS)
[Time Frame: Baseline, up to 5 years (End of Study)]
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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