Last updated on December 2019

Efficacy and Safety of Etripamil for the Termination of Spontaneous PSVT. NODE-301


Brief description of study

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.

Detailed Study Description

NODE-301 is a multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a nasal spray of etripamil, a new calcium channel blocker, in patients who experience an episode of paroxysmal ventricular tachycardia (PSVT).

The study will comprise of 2 parts, Part 1 and Part 2. Part 1 will consist of patients that will be dosed with the double-blind study drug or have discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode. The data from patients in Part 1 will be cleaned and locked, on a per-patient basis, and will be included in pivotal analyses. Pivotal analyses will include safety; and primary, secondary, and exploratory efficacy analyses for Part 1 only. Patients in Part 1 will be unblinded after data is locked.

Part 2 will consist of patients that will not be included in Part 1, i.e., Part 2 will consist of patients who were not dosed with the double-blind study drug or have not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode. The data from patients in Part 2 will be combined with that from Part 1 and will be included in exploratory analyses. Exploratory analyses will include safety; and primary, secondary, and exploratory efficacy analyses for Parts 1 and 2 combined. Patients in Part 2 will be unblinded at the end of the study. Part 2 will end when one of the following criteria is met:

  • 75% of patients in Part 2 have completed the study (Final Study Visit), or
  • Approximately 9 months after the date of the adjudication of the 150th positively adjudicated PSVT episode.

Based on the results of the pivotal analyses from Part 1, the planned statistical analysis and conduct of Part 2 may be amended. However, in no case will the Part 2 dataset be integrated with the Part 1 pivotal dataset for primary efficacy or primary safety analyses.

The study will include a Screening Visit, a Test Dose Randomization Visit, Follow-up Visits, a Treatment Period, and a Final Study Visit.

Clinical Study Identifier: NCT03464019

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Alpine Research Organization, Inc

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