Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Pfizer Investigational Site
      • DOLE Saint YLIE, France, 39108
        • Pfizer Investigational Site
      • LYON cedex, France, 69373
        • Pfizer Investigational Site
      • Lievin, France, 62800
        • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
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])
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
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]
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
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])
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
Baseline, up to 5 years (End of Study [LOCF])

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Scores on Patient Preference Scale (PPS)
Time Frame: Baseline, up to 5 years (End of Study)
Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.
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)
DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.
Baseline, up to 5 years (End of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe