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

Milestone Pharmaceuticals Inc.0 个研究点目标入组 700 人开始时间: 2020年10月13日最近更新: 2021年8月17日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Milestone Pharmaceuticals Inc.
入组人数: 700

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 clinical trial of medicinal product

入排标准

性别: All

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., 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
•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 an approved 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 an approved form of contraception between the visits. Approved forms of contraception include hormonal intrauterine devices or hormonal contraceptives (oral birth control pills, Depo-Provera?, patch, or other injectables) together with a supplementary barrier method, such as condoms or diaphragms with spermicidal gel or foam;
•The following categories define females who are NOT considered to be of childbearing potential:
•Premenopausal females with 1 of the following:
•Documented hysterectomy;
•Documented bilateral salpingectomy or tubal ligation; or
•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 an approved highly effective
•form of contraception during the 3 days after any study drug administration; and
•6. Signed written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

排除标准

•Patients who meet any of the following criteria will be excluded from participation in the study:
•1. Systolic blood pressure <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 and patients may be rescreened once;
•2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
•3. History of atrial arrhythmia that does not involve the 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 sustained ventricular tachycardia);
•10. Current congestive heart failure defined by the New York Heart Association Class II to IV;
•11. History of Acute Coronary Syndrome or stroke 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 renal dysfunction as determined by an estimated glomerular filtration rate assessed
•at the Screening Visit as follows:
•<60 mL/min/1.73 m2 for patients <60 years of age;
•<40 mL/min/1.73 m2 for patients =60 and <70 years of age; or
•<35 mL/min/1.73 m2 for patients =70 years of age;
•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 Inc.

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