NCT01610037已完成3 期
A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,215
- 试验地点
- 1
- 主要终点
- Number of Patients With Serious Adverse Events
研究概览
简要总结
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
QVA149
Experimental
干预措施: QVA149 (Drug)
Tiotropium
Active Comparator
干预措施: Tiotropium (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of Patients With Serious Adverse Events
时间窗: Week 52
The overall rate of serious adverse events reported from initiation through 30 days post last dose.
次要结局
- Change From Baseline in Percentage of no Daytime Symptoms(52 weeks)
- Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)(Day 22, 43, 85, 183, 274 and 364)
- Change From Baseline in 1 Hour Post-dose FEV1 Measurements(Day 1, 22, 43, 85, 183, 274 and 364)
- Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE(52 weeks)
- Change From Baseline in Daily, Morning and Evening Symptom Scores(52 weeks)
- Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.(52 weeks)
- Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)(Measurment at day 364)
- Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings(52 weeks)
- Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.(52 weeks)
- Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements(Day 1, 22, 43, 85, 183, 274 and 364)
- Time to Premature Discontinuation(Time varied from 5 - 407 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Assess the Long-term Safety of QVA149Chronic Obstructive Pulmonary DiseaseNCT01120717Novartis Pharmaceuticals339
已完成
3 期
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT01529632Novartis Pharmaceuticals193
已完成
3 期
An Investigational Drug in Patients With Osteoarthritis (0663-073)OsteoarthritisNCT00092755Organon and Co548
已完成
3 期
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)OsteoarthritisNCT00092768Organon and Co500
已完成
3 期
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)OsteoarthritisNCT00092781Organon and Co500