JPRN-jRCT2080223509已完成3 期
A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
ovartis Pharma K.K.0 个研究点目标入组 200 人开始时间: 2017年4月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients completing a prior Phase 3 study of QAW039:
- •*Informed consent and assent (if applicable).
- •*Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
- •*Patient is able to safely continue into the study as judged by the investigator.
- •Patients who have not previously participated in a study of QAW039:
- •*Written informed consent.
- •*A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
- •*Evidence of airway reversibility or airway hyper- reactivity.
- •*FEV1 of >=40% and =<85% of the predicted normal value.
- •*An ACQ score >=1.5 prior to entering the study.
排除标准
- •Patients completing a prior phase 3 study of QAW039:
- •*Pregnant or nursing (lactating) women.
- •*Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug.
- •*Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
- •*Inability to comply with all study requirements.
- •*Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.
- •*Patient who developed a condition during the prior study that would have excluded them from participation in that study.
- •Patients who have not previously participated in a study of QAW039:
- •*Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
- •*Subjects who have participated in another trial of QAW039.
- •*A QTcF (Fridericia) >=450 msec (male) or >=460 msec (female).
- •*History of malignancy with the exception of local basal cell carcinoma of the skin.
- •*Pregnant or nursing (lactating) women.
- •*Serious co-morbidities.
- •*Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
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