NCT01263808已完成1 期
A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Change from baseline in QTc interval (Fridericia's)
研究概览
简要总结
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking
- •Body mass index (BMI) 18.5-32 kg/m2
- •Body weight at least 50 kg
排除标准
- •Recent/concurrent use of concomitant medications (except acetaminophen)
- •Recent participation in other clinical trials
- •Recent donation or loss of blood
- •History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol 150 µg
Experimental
Indacaterol 150 µg
干预措施: Indacaterol 150 µg (Drug)
Indacaterol 300 µg
Experimental
Indacaterol 300 µg
干预措施: Indacaterol 300 µg (Drug)
Indacaterol 600 µg
Experimental
Indacaterol 600 µg
干预措施: Indacaterol 600 µg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Placebo/moxifloxacin
Active Comparator
Placebo/moxifloxacin
干预措施: Placebo/moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in QTc interval (Fridericia's)
时间窗: Change from baseline (prior to the first dose) to Day 14
次要结局
- Change from baseline in uncorrected QT interval(Change from baseline (prior to the first dose) to Day 14)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Different Doses of IndacaterolAsthmaNCT01079130Novartis Pharmaceuticals511
已完成
3 期
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT01089127Novartis Pharmaceuticals552
已完成
2 期
Efficacy, Safety and Pharmacokinetics of Different Regimens of IndacaterolPersistent AsthmaNCT01156844Novartis Pharmaceuticals191
已完成
2 期
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent AsthmaAsthmaNCT00545272Novartis Pharmaceuticals392
已完成
2 期
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)COPDNCT00557466Novartis568