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

Study Overview
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Brief Summary
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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).

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ziprasidone|20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to 72 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-label extension Ziprasidone study in Schizophrenia