EUCTR2011-005673-23-GR进行中（未招募）不适用
A 12-week multi-center, randomized, double-blind, parallel-group study to assess the efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe COPD - GLOW6
ovartis Pharma Service AG0 个研究点目标入组 450 人开始时间: 2012年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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 with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
- •2. Patients with a post-bronchodilator FEV1 = 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years
- •4. Symptomatic patients according to daily diary data.
- •Other protocol defined inclusion criteria may apply
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Pregnant or nursing (lactating) women.
- •2. Women of child-bearing potential.
- •3. Patients with Type I or uncontrolled Type II diabetes.
- •4. Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia method) is prolonged
- •5. Patients with paroxysmal (e.g. intermittent) atrial fibrillation
- •6. Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
- •Other protocol defined exclusion criteria may apply
研究者
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