NCT00643448已完成2 期
A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship Between QTcF Interval at First Dose (Loading Dose) and at Steady State After Treatment With AZD1305 Extended-release Tablets or Placebo When Given to Patients With Documented AF
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Maximum QTcF
研究概览
简要总结
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
- •Sinus rhythm at randomisation
排除标准
- •Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
- •Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
- •Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
- •QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
- •Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
- •QRS duration >120 ms at randomisation
- •Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth
研究组 & 干预措施
Placebo corresponding to AZD1305 loading dose
Placebo Comparator
Tablets
干预措施: Placebo (Drug)
AZD1305 loading dose 250 mg + 125 mg
Experimental
Tablets
干预措施: AZD1305 (Drug)
AZD1305 loading dose 500 mg + placebo
Experimental
Tablets
干预措施: AZD1305 (Drug)
结局指标
主要结局
Maximum QTcF
时间窗: During treatment days 2-10
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
次要结局
- Adverse Events (AE)(During treatment days 2-10)
- Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state(During treatment days 1-10)
- Compliance With Trans Telephonic Monitoring (TTM)(During treatment days 1-10)
研究者
研究点 (1)
Loading locations...
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