Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
NCT ID: NCT00139737
Last Updated: 2021-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2002-03-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Ziprasidone
20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Sora, Frosinone, Italy
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Parma, PR, Italy
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Acri, CS, , Italy
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Arezzo, , Italy
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Arona (No), , Italy
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Bassano del Grappa, , Italy
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Bisceglie (BA), , Italy
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Bologna, , Italy
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Bologna, , Italy
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Bolzano, , Italy
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Brindisi, , Italy
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Cagliari, , Italy
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Casalecchio Di Reno BO, , Italy
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Caserta, , Italy
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Catania, , Italy
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Cefalu' (Pa), , Italy
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Cesena FO, , Italy
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Chiari (Bs), , Italy
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Cremona, , Italy
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Crotone, , Italy
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Cuneo, , Italy
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Dolo (Ve), , Italy
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Empoli, , Italy
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Enna, , Italy
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Fano (PS), , Italy
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Formia (LT), , Italy
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Frattaminore (NA), , Italy
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Genova, , Italy
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Genova, , Italy
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Genova, , Italy
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Genzano (RM), , Italy
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Giarre, CT, , Italy
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Guardiagrele (CH), , Italy
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Lamezia Terme, , Italy
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Lecce, , Italy
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Livorno, , Italy
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L’Aquila, , Italy
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Matera, , Italy
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Melzo (MI), , Italy
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Merano (BZ), , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Montebelluna (TV), , Italy
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Montecchio Maggiore (VI), , Italy
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Montevarchi (AR), , Italy
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Monza MI, , Italy
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Napoli, , Italy
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Nocera Inferiore, SA, , Italy
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Noto, , Italy
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Novi Ligure, AL, , Italy
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Orbassano, to, , Italy
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Padua, , Italy
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Palermo, , Italy
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Palermo, , Italy
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Palermo, , Italy
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Partinico (Pa), , Italy
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Passirana Di Rho (Mi), , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Pordenone, , Italy
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Portogruaro (Ve), , Italy
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Puglianello (BN), , Italy
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Ragusa, , Italy
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Reggio Calabria, , Italy
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Rivoli, to, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Salerno, , Italy
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San Benedetto Del Tronto, AP, , Italy
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San Giorgio Di Piano BO, , Italy
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San Marco in Lamis FG, , Italy
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Sant'Arsenio (SA), , Italy
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Sassari, , Italy
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Senigallia, AN, , Italy
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Spoleto (PG), , Italy
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Taranto, , Italy
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Tivoli (RM), , Italy
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Torino, , Italy
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Torino, , Italy
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Treviso, , Italy
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Udine, , Italy
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Verona, , Italy
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Viareggio, , Italy
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1281061
Identifier Type: -
Identifier Source: org_study_id
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