Clinical trial NCT00139737: Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Open-label extension Ziprasidone study in Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sora
country: Italy
facility: Pfizer Investigational Site
state: Frosinone
city: Parma
country: Italy
facility: Pfizer Investigational Site
state: PR
city: Acri, CS
country: Italy
facility: Pfizer Investigational Site
city: Arezzo
country: Italy
facility: Pfizer Investigational Site
city: Arona (No)
country: Italy
facility: Pfizer Investigational Site
city: Bassano del Grappa
country: Italy
facility: Pfizer Investigational Site
city: Bisceglie (BA)
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bolzano
country: Italy
facility: Pfizer Investigational Site
city: Brindisi
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Casalecchio Di Reno BO
country: Italy
facility: Pfizer Investigational Site
city: Caserta
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Cefalu' (Pa)
country: Italy
facility: Pfizer Investigational Site
city: Cesena FO
country: Italy
facility: Pfizer Investigational Site
city: Chiari (Bs)
country: Italy
facility: Pfizer Investigational Site
city: Cremona
country: Italy
facility: Pfizer Investigational Site
city: Crotone
country: Italy
facility: Pfizer Investigational Site
city: Cuneo
country: Italy
facility: Pfizer Investigational Site
city: Dolo (Ve)
country: Italy
facility: Pfizer Investigational Site
city: Empoli
country: Italy
facility: Pfizer Investigational Site
city: Enna
country: Italy
facility: Pfizer Investigational Site
city: Fano (PS)
country: Italy
facility: Pfizer Investigational Site
city: Formia (LT)
country: Italy
facility: Pfizer Investigational Site
city: Frattaminore (NA)
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Genzano (RM)
country: Italy
facility: Pfizer Investigational Site
city: Giarre, CT
country: Italy
facility: Pfizer Investigational Site
city: Guardiagrele (CH)
country: Italy
facility: Pfizer Investigational Site
city: L'Aquila
country: Italy
facility: Pfizer Investigational Site
city: Lamezia Terme
country: Italy
facility: Pfizer Investigational Site
city: Lecce
country: Italy
facility: Pfizer Investigational Site
city: Livorno
country: Italy
facility: Pfizer Investigational Site
city: Matera
country: Italy
facility: Pfizer Investigational Site
city: Melzo (MI)
country: Italy
facility: Pfizer Investigational Site
city: Merano (BZ)
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Montebelluna (TV)
country: Italy
facility: Pfizer Investigational Site
city: Montecchio Maggiore (VI)
country: Italy
facility: Pfizer Investigational Site
city: Montevarchi (AR)
country: Italy
facility: Pfizer Investigational Site
city: Monza MI
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Nocera Inferiore, SA
country: Italy
facility: Pfizer Investigational Site
city: Noto
country: Italy
facility: Pfizer Investigational Site
city: Novi Ligure, AL
country: Italy
facility: Pfizer Investigational Site
city: Orbassano, TO
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Partinico (Pa)
country: Italy
facility: Pfizer Investigational Site
city: Passirana Di Rho (Mi)
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Pordenone
country: Italy
facility: Pfizer Investigational Site
city: Portogruaro (Ve)
country: Italy
facility: Pfizer Investigational Site
city: Puglianello (BN)
country: Italy
facility: Pfizer Investigational Site
city: Ragusa
country: Italy
facility: Pfizer Investigational Site
city: Reggio Calabria
country: Italy
facility: Pfizer Investigational Site
city: Rivoli, TO
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Salerno
country: Italy
facility: Pfizer Investigational Site
city: San Benedetto Del Tronto, AP
country: Italy
facility: Pfizer Investigational Site
city: San Giorgio Di Piano BO
country: Italy
facility: Pfizer Investigational Site
city: San Marco In Lamis FG
country: Italy
facility: Pfizer Investigational Site
city: Sant'Arsenio (SA)
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Senigallia, AN
country: Italy
facility: Pfizer Investigational Site
city: Spoleto (PG)
country: Italy
facility: Pfizer Investigational Site
city: Taranto
country: Italy
facility: Pfizer Investigational Site
city: Tivoli (RM)
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Treviso
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Verona
country: Italy
facility: Pfizer Investigational Site
city: Viareggio
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: