Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia;The RAPID Study (NODE-301 Part 2) - RAPID - NODE-301

Milestone Pharmaceuticals0 个研究点目标入组 21 人开始时间: 待定最近更新: 2024年4月9日

试验速览

阶段: 3 期
状态: 已完成
发起方: Milestone Pharmaceuticals
入组人数: 21

研究概览入排标准研究者记录与标识符相似试验

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: 18 至 99（—）

入选标准

•Patients who meet all of the following criteria will be eligible to participate
•in the study:
•1. Male or female patients at least 18 years of age;
•2. Electrographically documented history of PSVT (e.g., electrocardiogram [ECG]
•obtained during an episode of PSVT, Holter monitoring, loop recorder, etc.). If
•patient had a prior ablation for PSVT, patient must have documented ECG
•evidence of PSVT post-ablation;
•3. History of sustained episodes of PSVT (i.e., typically lasting approximately
•20 minutes or longer);
•4. Females of childbearing potential who are sexually active with a male
•partner who is not surgically sterile (i.e., vasectomy) must agree to use a
•highly effective form of contraception from the time of signed informed consent
•until 30 days after the last administration of study drug. Females of
•childbearing potential should have a negative serum pregnancy test result at
•the Screening Visit and at the Final Study Visit, a negative urine pregnancy
•test at the Test Dose Randomization Visit and must use a highly effective form
•of contraception between the visits.
•The following categories define females who are NOT considered to be of
•childbearing potential:
•Premenopausal females with 1 of the following:
•a. Documented hysterectomy;
•b. Documented bilateral salpingectomy or tubal ligation; or
•c. Documented bilateral oophorectomy; or
•Postmenopausal females, defined as having amenorrhea for at least 12 months
•without an alternative medical cause;
•5. Male patients, except those who are surgically sterile, must use a highly
•effective form of contraception during the 3 days after any study drug
•administration; and
•6. Signed written informed consent.

排除标准

•Patients who meet any of the following criteria will be excluded from
•participation in the study:
•1. Systolic blood pressure (SBP) <90 mmHg after a 5-minute rest in sitting
•position at the Screening Visit or before the test dose. In patients treated
•with a chronic prophylactic drug for PSVT (e.g., beta blockers, verapamil, and
•diltiazem), the drug may be stopped for at least the equivalent of 5
•half-lives, patients may be rescreened once, and chronic use of the drug cannot
•be restarted after randomization.
•2. History of severe symptoms of hypotension, especially syncope, during
•episodes of PSVT;
•3. 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);
•4. History of allergic reaction to verapamil;
•5. Current therapy with digoxin or any Class I or III antiarrhythmic drug,
•except if these drugs are stopped at least the equivalent of 5 half-lives
•before the Test Dose Randomization Visit;
•6. Current chronic therapy with oral amiodarone, or have taken oral amiodarone
•within 30 days prior to the Test Dose Randomization Visit;
•7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval
•<100 msec, Wolff Parkinson White syndrome) on the ECG performed at the
•Screening Visit or before the test dose administration;
•8. Evidence of a second- or third-degree AV block on the ECG performed at the
•Screening Visit or before the test dose administration;
•9. History or evidence of severe ventricular arrhythmia (e.g., torsades de
•pointes, ventricular fibrillation, or ventricular tachycardia);
•10. Current congestive heart failure defined by the New York Heart Association
•Class II to IV;
•11. Stroke in the last within 6 months of screening;
•12. Evidence of hepatic dysfunction defined as alanine aminotransferase or
•aspartate aminotransferase >3 × the upper limit of normal (ULN) or total
•bilirubin >2 × ULN at the Screening Visit, unless due to Gilbert syndrome;
•13. Evidence of End-Stage Renal Disease as determined by an estimated
•glomerular filtration rate assessed at the Screening Visit of <15mL/min/1.73m2
•or requiring hemodialysis;
•14. Females who are pregnant or lactating;
•15. Evidence or history of any significant physical or psychiatric condition
•including drug abuse, which, in the opinion of the Investigator, could
•jeopardize the safety of patients or affect their participation in the study.
•Additionally, the Investigator has the ability to exclude a patient if for any
•reason the Investigator judges the patient is not a good candidate for the
•study or will not be able to follow study procedures;
•16. Participation in any investigational drug or device study or the use of any
•investigational drug or device within 30 days of the Screening Visit; or
•17. Previously enrolled in a clinical trial for etripamil and received study
•drug during a perceived episode of PSVT.

研究者

发起方

Milestone Pharmaceuticals

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