JPRN-jRCT2031190069招募中2 期
First-in-Patient Study for single dose of M201-A hydrochloride injection in Japanese patients with paroxysmal atrial fibrillation
Kumagai Yuji0 个研究点目标入组 42 人开始时间: 2019年8月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •(1) Japanese (male, female) adult with symptomatic paroxysmal atrial fibrillation (AF)
- •- Written informed consent must be obtained on a voluntary basis before any assessment is performed.
- •(2) Age: 20 to less than 85 years of age
- •(3) Weight: 40 kilograms(kg) or more
- •BMI: 18.5 to less than 28.0 on screening examination(screening)
- •(4) Past AF History: Event(s) as symptomatic AF with (at least) 2 hours or more AF lasting has (have) occurred at least once or more a half year (6 months) prior to the screening.
- •(5) Occurrence time of the latest AF: Record(s) of the patient portable electrocardiograph shows evidence to support that the latest AF has occurred within 3 hours to less than 3 days (72 hours) prior to an administration of the investigational product.
- •(6) The AF lasting prior to the administration: 12 lead electrocardiogram just prior to the administration shows that AF has not stopped.
- •(7) Excluded medication: Based on propositions of a principal investigator or a co-investigator(s), a patient can consent for discontinuation of below antiarrhythmic agents (the Vaughan-Williams classification) for at least 7 days after administration since an advanced registration. Nonetheless, if a period between the advanced registration and the administration is less than 7 days, it should be confirmed those agent has unadministered during 7 days prior to the administration.
- •[Vaughan-Williams classification]
- •Antiarrhythmic drug group I
- •Antiarrhythmic drug group III
- •Antiarrhythmic drug group IV Bepridil (Bepricol)
- •(8) Excluded administration of amiodarone: It should be confirmed that amiodarone hydrochloride is not unadministered within one (1) year before the screening.
排除标准
- •(1) Heart failure (NYHA II, III, IV). Excluding palpitations induced by atrial fibrillation (AF)
- •(2) Any atrioventricular block of first, second or third degree at the time of sinus rhythm
- •(3) Any risk factor leads to Torsades de Pointes (TdP)
- •a) QTcF: 440 ms or more in standard 12-lead electrocardiogram at the time of sinus rhythm within 3 months prior to administration
- •b) Hypokalemia or suspected to be hypokalemia:
- •One or more of serum potassium levels, obtained at any time during 6 months in advance of administration including pre-administration examination, has been 3.6 mEq/L or less.
- •c) Hypomagnesemia or suspected be hypomagnesemia: One or more of serum magnesium levels, obtained at any time during 6 months in advance of administration including pre-administration examination, has been 1.8 mg/dL or less.
- •d) T-wave abnormality of electrocardiogram at the time of sinus rhythm
- •e) Past medical history as fainting; syncope with unknown etiology or complicating illness.
- •f) Past own medical history or family medical history as long QT syndrome
- •(4) Severe heart hypertrophy; Cardiomegaly: Septal Thickness of cardiac ultrasound has been exceeded over 15 mm.
- •(5) Left atrial dimension (parasternal long-axis view) of cardiac ultrasound has been exceeded over 45 mm.
研究者
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