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Calcium Channel Blocker
Etripamil for Atrial Fibrillation
Phase 2
Waitlist Available
Led By Denis Roy, M.D
Research Sponsored by Milestone Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes post drug administration
Awards & highlights
Study Summary
This trial demonstrates that etripamil is more effective than placebo in reducing ventricular rate for AF patients, and is safe and well tolerated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes post drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes post drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The maximum reduction in ventricular rate, measured on Holter monitoring, within 60 minutes from drug administration.
Secondary outcome measures
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
The elapsed time from drug administration to nadir (lowest average heart rate) in the 60 minutes post drug administration.
The percentage of patients achieving ventricular rate of <100 bpm in the 60 minutes post drug administration.
+3 moreSide effects data
From 2016 Phase 2 trial • 199 Patients • NCT0229619045%
Nasal congestion
35%
Nasal Discomfort
35%
Throat Irritation
20%
Oropharyngeal pain
15%
Headache
10%
Cough
10%
Vomiting
5%
Catheter site bruise
5%
Acute Respiratory Failure
5%
Oral Discomfort
5%
Urinary Retention
5%
Bundle Branch Block Right
5%
Catheter site haematoma
5%
Rhinorrhea
5%
Increased lacrimation
5%
Nausea
5%
Hypotension
5%
Paraesthesia
5%
Back Pain
5%
Dysgeusia
5%
Facial Flushing
5%
Procedural Pain
5%
Cerebrovascular disorder
5%
Sedation
5%
Vision Blurred
5%
Visual Impairment
5%
Constipation
5%
Petechiae
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etripamil_105 mg
Etripamil_70 mg
Placebo
Etripamil_140 mg
Open Label Etripamil 70 mg
Etripamil_35 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EtripamilExperimental Treatment1 Intervention
Patients will receive a total of 200 μL of etripamil Nasal spray 70 mg via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive a total of 200 μL of placebo ((i.e. 100 μL in each nostril) via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etripamil
2015
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,817 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,238 Patients Enrolled for Atrial Fibrillation
Milestone Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
3,288 Total Patients Enrolled
JSS Medical Research Inc.Industry Sponsor
18 Previous Clinical Trials
5,426 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stroke, mini-stroke, or blood clot in your limbs within the past 3 months.You have a serious narrowing in your heart valves that has not been fixed.You have a serious health condition that could put your safety at risk or affect the accuracy of the study results.If you have atrial fibrillation, you need to be receiving the right medication to prevent blood clots, as recommended by your doctor.You have a history of a type of heart block called second- or third-degree atrioventricular block.You have a history or signs of certain heart rhythm problems called torsades de pointes, sick sinus syndrome, or Brugada syndrome.The study drug etripamil is only used for short-term heart rate control. If you need long-term control of your heart rhythm, you may require additional medications and blood thinners as per medical guidelines.Your heart beats in a regular rhythm that indicates a complete block in the electrical signals between the upper and lower chambers of the heart.You had a heart attack in the past year, unless you had a successful procedure to fix it.You have had an allergic reaction to any parts of the experimental medication.You are showing serious signs of heart failure, like difficulty breathing, low oxygen levels, crackling sounds in your lungs, and poor blood circulation in your extremities.You have had a bad reaction to verapamil in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Etripamil
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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