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ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2

NCT04467905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-09-19

Study results available
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Summary

Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study were to demonstrate the superiority of a nasal spray of etripamil over placebo in reducing ventricular rate in patients with AF; and to evaluate the safety and efficacy of etripamil nasal spray in participants with AF.

Conditions

Interventions

DRUG

Etripamil

The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.

DRUG

Placebo

The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.

Sponsors & Collaborators

  • The Montreal Health Innovations Coordinating Center (MHICC)

    collaborator OTHER

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Milestone Pharmaceuticals Inc.

    lead OTHER

Principal Investigators

  • Denis Roy, M.D · Montreal Heart Institute (MHI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-08-03
Completion
2023-08-10
FDA Drug
Yes

Countries

  • Canada
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467905 on ClinicalTrials.gov