NL-OMON50059撤回3 期
Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia - Milestone NODE-303
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 50
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Has been diagnosed with PSVT by a medical professional and reports having at
- •least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT
- •that includes the AV node as a critical part of reentrant circuit.
- •2) Is of at least 18 years of age
- •3) Signed NODE-303 written informed consent
- •4) Women of child-bearing potential must be willing to use at least 1 form of
- •contraception during the trial, and must be willing to discontinue from the
- •study should they become or plan to become pregnant
- •5) Willing and able to comply with study procedures
排除标准
- •1) Patients with only a history of atrial arrhythmia that does not involve the
- •atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial
- •fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible.
- •Patients with a history of these tachycardias who are also diagnosed with PSVT
- •are eligible.
- •2) History of allergic reaction to verapamil
- •3) Current therapy with digoxin, or any Class I or III antiarrhythmic drug.
- •Patients may be eligible if these drugs are stopped at least five half-lives
- •before the administration of etripamil NS. The only exception is amiodarone
- •which must be stopped 30 days before enrollment.
- •4) History of ventricular pre-excitation, e.g., delta waves,
- •Wolff-Parkinson-White syndrome.
- •5) History of a second- or third-degree AV block
- •6) Symptoms of congestive heart failure New York Heart Association Class II to
- •7) Significant physical or psychiatric condition including alcoholism or drug
- •abuse, which, in the opinion of the Investigator, could jeopardize the safety
- •of the patient, or impede the patient*s capacity to follow the study procedures
- •8) History of syncope due to an arrhythmic etiology at any time, or history in
- •last 5 years of unexplained syncope
- •9) Is pregnant or breastfeeding
- •10) Previously enrolled in a clinical trial for etripamil and received study
- •11) History of ACS or stroke within 6 months of screening
- •12) Evidence of renal dysfunction as determined by an estimated glomerular
- •filtration rate assessed at the Screening Visit as follows:
- •a) < 60mL/min/1.73m2 for patients < 60 years of age
- •b) < 40mL/min/1.73m2 for patients >=60 and < 70 years of age
- •c) < 35mL/min/1.73m2 for patients >=70 years of age
研究者
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