NCT00125320已完成3 期
A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 22
- 主要终点
- Effectiveness of RSD1235
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
详细描述
This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery
排除标准
- •Unstable Class IV heart failure
结局指标
主要结局
Effectiveness of RSD1235
时间窗: 90 minutes post infusion
次要结局
- Proportion of patients in sinus rhythm at 90 minutes(Time from first exposure to conversion to sinus rhythm)
研究者
研究点 (22)
Loading locations...
相似试验
已完成
3 期
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial FlutterAtrial FibrillationAtrial FlutterNCT00115791Astellas Pharma Inc276
已完成
3 期
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial FibrillationAtrial FibrillationNCT00468767Advanz Pharma356
已完成
3 期
A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and ExerciseType 2 DiabetesNCT06672172Shandong Suncadia Medicine Co., Ltd.284
已完成
3 期
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17Attention Deficit Disorder With HyperactivityNCT00150618Shire324
已完成
3 期
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer PainPainNCT01165281Janssen Research & Development, LLC343