Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

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

Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study

To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

344

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

  • Italy
      • Acri, CS, Italy, 87041
        • Pfizer Investigational Site
      • Arezzo, Italy, 52100
        • Pfizer Investigational Site
      • Arona (No), Italy, 28041
        • Pfizer Investigational Site
      • Bassano del Grappa, Italy, 36061
        • Pfizer Investigational Site
      • Bisceglie (BA), Italy, 70052
        • Pfizer Investigational Site
      • Bologna, Italy, 40100
        • Pfizer Investigational Site
      • Bologna, Italy, 40122
        • Pfizer Investigational Site
      • Bolzano, Italy, 39100
        • Pfizer Investigational Site
      • Brindisi, Italy, 72100
        • Pfizer Investigational Site
      • Cagliari, Italy, 09100
        • Pfizer Investigational Site
      • Casalecchio Di Reno BO, Italy, 40033
        • Pfizer Investigational Site
      • Caserta, Italy, 81100
        • Pfizer Investigational Site
      • Catania, Italy, 95127
        • Pfizer Investigational Site
      • Cefalu' (Pa), Italy, 90015
        • Pfizer Investigational Site
      • Cesena FO, Italy, 47023
        • Pfizer Investigational Site
      • Chiari (Bs), Italy, 25032
        • Pfizer Investigational Site
      • Cremona, Italy, 26100
        • Pfizer Investigational Site
      • Crotone, Italy, 88900
        • Pfizer Investigational Site
      • Cuneo, Italy, 12100
        • Pfizer Investigational Site
      • Dolo (Ve), Italy, 30030
        • Pfizer Investigational Site
      • Empoli, Italy, 50053
        • Pfizer Investigational Site
      • Enna, Italy, 94100
        • Pfizer Investigational Site
      • Fano (PS), Italy, 61032
        • Pfizer Investigational Site
      • Formia (LT), Italy, 04023
        • Pfizer Investigational Site
      • Frattaminore (NA), Italy, 80020
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Genova, Italy, 16149
        • Pfizer Investigational Site
      • Genova, Italy, 16165
        • Pfizer Investigational Site
      • Genzano (RM), Italy, 00045
        • Pfizer Investigational Site
      • Giarre, CT, Italy, 95014
        • Pfizer Investigational Site
      • Guardiagrele (CH), Italy, 66016
        • Pfizer Investigational Site
      • L'Aquila, Italy, 67100
        • Pfizer Investigational Site
      • Lamezia Terme, Italy, 88046
        • Pfizer Investigational Site
      • Lecce, Italy, 73100
        • Pfizer Investigational Site
      • Livorno, Italy, 57100
        • Pfizer Investigational Site
      • Matera, Italy, 75100
        • Pfizer Investigational Site
      • Melzo (MI), Italy, 26066
        • Pfizer Investigational Site
      • Merano (BZ), Italy, 39012
        • Pfizer Investigational Site
      • Milano, Italy, 20100
        • Pfizer Investigational Site
      • Milano, Italy, 20122
        • Pfizer Investigational Site
      • Milano, Italy, 20142
        • Pfizer Investigational Site
      • Montebelluna (TV), Italy, 31044
        • Pfizer Investigational Site
      • Montecchio Maggiore (VI), Italy, 36075
        • Pfizer Investigational Site
      • Montevarchi (AR), Italy, 52025
        • Pfizer Investigational Site
      • Monza MI, Italy, 20052
        • Pfizer Investigational Site
      • Napoli, Italy, 80136
        • Pfizer Investigational Site
      • Nocera Inferiore, SA, Italy, 84014
        • Pfizer Investigational Site
      • Noto, Italy, 96017
        • Pfizer Investigational Site
      • Novi Ligure, AL, Italy
        • Pfizer Investigational Site
      • Orbassano, TO, Italy, 10043
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Palermo, Italy, 90127
        • Pfizer Investigational Site
      • Palermo, Italy, 90100
        • Pfizer Investigational Site
      • Palermo, Italy, 90145
        • Pfizer Investigational Site
      • Partinico (Pa), Italy, 90047
        • Pfizer Investigational Site
      • Passirana Di Rho (Mi), Italy, 20017
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Perugia, Italy, 06127
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
      • Pordenone, Italy, 33170
        • Pfizer Investigational Site
      • Portogruaro (Ve), Italy, 30026
        • Pfizer Investigational Site
      • Puglianello (BN), Italy, 82030
        • Pfizer Investigational Site
      • Ragusa, Italy, 97100
        • Pfizer Investigational Site
      • Reggio Calabria, Italy, 89100
        • Pfizer Investigational Site
      • Rivoli, TO, Italy, 10098
        • Pfizer Investigational Site
      • Roma, Italy, 00144
        • Pfizer Investigational Site
      • Roma, Italy, 00133
        • Pfizer Investigational Site
      • Roma, Italy, 00149
        • Pfizer Investigational Site
      • Roma, Italy, 00152
        • Pfizer Investigational Site
      • Salerno, Italy, 84100
        • Pfizer Investigational Site
      • San Benedetto Del Tronto, AP, Italy, 63039
        • Pfizer Investigational Site
      • San Giorgio Di Piano BO, Italy, 40016
        • Pfizer Investigational Site
      • San Marco In Lamis FG, Italy, 71014
        • Pfizer Investigational Site
      • Sant'Arsenio (SA), Italy, 84037
        • Pfizer Investigational Site
      • Sassari, Italy, 07100
        • Pfizer Investigational Site
      • Senigallia, AN, Italy, 60019
        • Pfizer Investigational Site
      • Spoleto (PG), Italy
        • Pfizer Investigational Site
      • Taranto, Italy, 74100
        • Pfizer Investigational Site
      • Tivoli (RM), Italy, 00019
        • Pfizer Investigational Site
      • Torino, Italy, 10154
        • Pfizer Investigational Site
      • Torino, Italy, 10147
        • Pfizer Investigational Site
      • Treviso, Italy, 31100
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
      • Verona, Italy, 37063
        • Pfizer Investigational Site
      • Viareggio, Italy, 55049
        • Pfizer Investigational Site
    • Frosinone
      • Sora, Frosinone, Italy, 03039
        • Pfizer Investigational Site
    • PR
      • Parma, PR, Italy, 43100
        • 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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have successfully completed a ziprasidone clinical study
  • Patients not hospitalised in an acute psychiatric service
  • Written, informed consent to participation.
  • Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued

Exclusion Criteria:

Psychiatric:

  • Subjects at immediate risk of committing harm to self or others
  • Subjects requiring concurrent treatment with non-study antipsychotic agents
  • Subjects requiring treatment with antidepressants or mood stabilizers
  • General:
  • Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
  • Acute or chronic heart disease
  • Clinically significant ECG abnormalities
  • Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)
  • Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
  • Subjects with serum K+ or Mg++ outside the normal range
  • Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
  • Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)
  • Pregnant or lactating women
  • Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
  • Subjects unable or unlikely to follow the study protocol
  • Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
  • Known hypersensitivity to ziprasidone or lactose

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 72 months
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Baseline up to 72 months

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.

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

March 1, 2002

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (ESTIMATE)

August 31, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281061

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.

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