EUCTR2015-000607-15-Outside-EU/EEA进行中（未招募）不适用
26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
- •2. The subjects must have received study medication in Study A1281132. In general, subjects should have completed at least 3 weeks of double-blind treatment before entering this open-label extension. However, subjects who have insufficient treatment response and have reached their maximum tolerated dose may enroll in the open-label extension as early as 1 week after the end of their titration.
- •3. In the investigator’s opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double-blind study (ie, in the opinion of the investigator, the benefits that the subject is likely to derive from continued participation must outweigh the risks).
- •4.Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:
- •Are instructed and agree to avoid pregnancy during the study.
- •Have a negative serum pregnancy test (?-hCG) at the baseline visit.
- •Use one of the following birth control methods:
- •an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), transdermal hormonal contraceptive (Ortho-Evra), or an injectable contraceptive (eg, Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or
- •a barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; or abstinence during the preceding double-blind study and intention to abstain from sexual activity throughout this extension study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 162
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who experienced a serious adverse event considered related to study medication during the preceding double-blind trial.
- •2. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persisting QT interval corrected using Fridericia’s formula (QTcF) greater than or equal to (?) 460 millisecond (msec) or increase from baseline of QTcF ? 60 msec) during the preceding study (subjects with an increase in QTcF of ? 60 msec but with QTcF less than or equal to (=) 400 msec will be reviewed on a case-by-case basis by the sponsor for possible inclusion in the study).
- •3. Subjects requiring any medications not allowed by the Concomitant Medication Table.
- •4. Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
- •5. Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the CDRS-R, or who are otherwise judged by the investigator as being at imminent risk of suicide.
- •6. Subjects who are judged by the investigator as being at imminent risk of homicide during the study.
研究者
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