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

Viatris

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Ziprasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139737

A1281061

Details and patient eligibility

About

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).

Enrollment

344 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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