NCT00139737已完成3 期
Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.88 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2002年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 88
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 72 months
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
次要结局
未报告次要终点
研究者
研究点 (88)
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