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 sites21 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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

•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;

Not specified