NODE 301

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

Objective

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting.

Eligibility

  • Electrographically documented history of PSVT (e.g., ECG obtained during an episode of PSVT, Holter monitoring, or loop recorder, etc.)
  • Females of childbearing potential 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 and should have a negative serum pregnancy test result at the Screening Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and have used an approved form of contraception between the 2 visits
  • Males, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after any study drug administration

NCT ID

NCT03464019