EUCTR2008-000663-42-IT进行中（未招募）不适用
A 26-week extension to a 26-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess safety, tolerability and efficacy of two doses of indacaterol (150 and 300 μg o.d.) in patients with chronic obstructive pulmonary disease. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
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. Patients must complete Stage 2 of the core study B2335S. 2. Written informed consent to participate in the extension must be obtained. 3. Patients must be able to comply with all study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who were randomized to open-label tiotropium in Study B2335S. 2. Patients who participated in Stage 1 of the core study (B2335S). 3. Patients discontinued irrespective of the reason from Stage 2 of the core study. 4. Patients who fail to comply with the core protocol requirements and procedures. 5. Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol. 6. Patients who in the Investigator?s opinion should not-participate in the extension study.
研究者
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