NCT00694720终止2 期
A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in the Apnea Hypopnea Index (AHI)
研究概览
简要总结
The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and <60 and majority of the apneas to be ≥60% central in origin.
排除标准
- •Subject on supplemental oxygen
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
12 subjects: 3 subjects per dose level
干预措施: placebo (Drug)
Dose Level 1
Experimental
干预措施: AVE0657 (Drug)
Dose Level 2
Experimental
干预措施: AVE0657 (Drug)
Dose Level 3
Experimental
干预措施: AVE0657 (Drug)
Dose Level 4
Experimental
干预措施: AVE0657 (Drug)
结局指标
主要结局
Change in the Apnea Hypopnea Index (AHI)
时间窗: 2 days
次要结局
- Safety and tolerability(5 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced CancerAdvanced CancersNCT00934128M.D. Anderson Cancer Center30
已完成
3 期
An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)BronchiolitisNCT00076973Organon and Co1,125
已完成
2 期
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis BronchiectasisBronchiectasisNCT00930982Bayer124
Unknown
1 期
Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.Cough Variant AsthmaNCT03319043Shanghai University of Traditional Chinese Medicine120
已完成
4 期
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the DiskusPulmonary Disease, Chronic ObstructiveNCT03240575Boehringer Ingelheim302