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SchizophreniaPhase 3NCT00139737

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

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 87 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Ziprasidone
Type of treatment
Pill or oral medicine
How many people
344 participants
Where
87 sitesItaly
Study dates
Mar 2002to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

Italy87 sites

  • Pfizer Investigational Site

    Acri, CS, 87041

  • Pfizer Investigational Site

    Arezzo, 52100

  • Pfizer Investigational Site

    Arona (No), 28041

  • Pfizer Investigational Site

    Bassano del Grappa, 36061

  • Pfizer Investigational Site

    Bisceglie (BA), 70052

  • Pfizer Investigational Site

    Bologna, 40100

  • Pfizer Investigational Site

    Bologna, 40122

  • Pfizer Investigational Site

    Bolzano, 39100

  • Pfizer Investigational Site

    Brindisi, 72100

  • Pfizer Investigational Site

    Cagliari, 09100

  • Pfizer Investigational Site

    Casalecchio Di Reno BO, 40033

  • Pfizer Investigational Site

    Caserta, 81100

  • Pfizer Investigational Site

    Catania, 95127

  • Pfizer Investigational Site

    Cefalu' (Pa), 90015

  • Pfizer Investigational Site

    Cesena FO, 47023

  • Pfizer Investigational Site

    Chiari (Bs), 25032

  • Pfizer Investigational Site

    Cremona, 26100

  • Pfizer Investigational Site

    Crotone, 88900

  • Pfizer Investigational Site

    Cuneo, 12100

  • Pfizer Investigational Site

    Dolo (Ve), 30030

  • Pfizer Investigational Site

    Empoli, 50053

  • Pfizer Investigational Site

    Enna, 94100

  • Pfizer Investigational Site

    Fano (PS), 61032

  • Pfizer Investigational Site

    Formia (LT), 04023

  • Pfizer Investigational Site

    Frattaminore (NA), 80020

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Genova, 16149

  • Pfizer Investigational Site

    Genova, 16165

  • Pfizer Investigational Site

    Genzano (RM), 00045

  • Pfizer Investigational Site

    Giarre, CT, 95014

  • Pfizer Investigational Site

    Guardiagrele (CH), 66016

  • Pfizer Investigational Site

    L’Aquila, 67100

  • Pfizer Investigational Site

    Lamezia Terme, 88046

  • Pfizer Investigational Site

    Lecce, 73100

  • Pfizer Investigational Site

    Livorno, 57100

  • Pfizer Investigational Site

    Matera, 75100

  • Pfizer Investigational Site

    Melzo (MI), 26066

  • Pfizer Investigational Site

    Merano (BZ), 39012

  • Pfizer Investigational Site

    Milan, 20100

  • Pfizer Investigational Site

    Milan, 20122

  • Pfizer Investigational Site

    Milan, 20142

  • Pfizer Investigational Site

    Montebelluna (TV), 31044

  • Pfizer Investigational Site

    Montecchio Maggiore (VI), 36075

  • Pfizer Investigational Site

    Montevarchi (AR), 52025

  • Pfizer Investigational Site

    Monza MI, 20052

  • Pfizer Investigational Site

    Naples, 80136

  • Pfizer Investigational Site

    Nocera Inferiore, SA, 84014

  • Pfizer Investigational Site

    Noto, 96017

  • Pfizer Investigational Site

    Novi Ligure, AL

  • Pfizer Investigational Site

    Orbassano, to, 10043

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Palermo, 90100

  • Pfizer Investigational Site

    Palermo, 90127

  • Pfizer Investigational Site

    Palermo, 90145

  • Pfizer Investigational Site

    Parma, PR, 43100

  • Pfizer Investigational Site

    Partinico (Pa), 90047

  • Pfizer Investigational Site

    Passirana Di Rho (Mi), 20017

  • Pfizer Investigational Site

    Pavia, 27100

  • Pfizer Investigational Site

    Perugia, 06127

  • Pfizer Investigational Site

    Pisa, 56126

  • Pfizer Investigational Site

    Pordenone, 33170

  • Pfizer Investigational Site

    Portogruaro (Ve), 30026

  • Pfizer Investigational Site

    Puglianello (BN), 82030

  • Pfizer Investigational Site

    Ragusa, 97100

  • Pfizer Investigational Site

    Reggio Calabria, 89100

  • Pfizer Investigational Site

    Rivoli, to, 10098

  • Pfizer Investigational Site

    Roma, 00133

  • Pfizer Investigational Site

    Roma, 00144

  • Pfizer Investigational Site

    Roma, 00149

  • Pfizer Investigational Site

    Roma, 00152

  • Pfizer Investigational Site

    Salerno, 84100

  • Pfizer Investigational Site

    San Benedetto Del Tronto, AP, 63039

  • Pfizer Investigational Site

    San Giorgio Di Piano BO, 40016

  • Pfizer Investigational Site

    San Marco in Lamis FG, 71014

  • Pfizer Investigational Site

    Sant'Arsenio (SA), 84037

  • Pfizer Investigational Site

    Sassari, 07100

  • Pfizer Investigational Site

    Senigallia, AN, 60019

  • Pfizer Investigational Site

    Sora, Frosinone, 03039

  • Pfizer Investigational Site

    Spoleto (PG)

  • Pfizer Investigational Site

    Taranto, 74100

  • Pfizer Investigational Site

    Tivoli (RM), 00019

  • Pfizer Investigational Site

    Torino, 10147

  • Pfizer Investigational Site

    Torino, 10154

  • Pfizer Investigational Site

    Treviso, 31100

  • Pfizer Investigational Site

    Udine, 33100

  • Pfizer Investigational Site

    Verona, 37063

  • Pfizer Investigational Site

    Viareggio, 55049

Other trials in Italy

About this study

Official title: 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).

Conditions
Schizophrenia
Being tested
Ziprasidone
Keywords
Open-label extension Ziprasidone study in Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiprasidoneDrug

    Also called Geodon, Zeldox

    20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

    Measured: Baseline up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2005 (estimated)
  2. Study startMar 2002
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00139737
Sponsor's protocol ID
A1281061
Status last verified
Mar 2021
First submitted
29 Aug 2005
Last updated
3 Mar 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 87 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00139737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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