Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spo… (NCT05410860) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
China500 participantsStarted 2022-06-30
Plain-language summary
To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home settingï¼› To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers.
To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients at least 18 years of age;
✓. Electrographically documented history of PSVT (e.g., diagnosis based on ECG , Holter monitoring, etc.). If patient had a prior ablation for PSVT, patient must have documented ECG evidence of PSVT post-ablation;
✓. History of sustained episodes of PSVT (i.e., typically lasting 20 minutes or longer);
✓. Females of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) 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.;
✓. Documented hysterectomy;
✓. Documented bilateral salpingectomy or tubal ligation; or
✓. Documented bilateral oophorectomy; or
✓. Signed written informed consent.
Exclusion criteria
✕. 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;
✕. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
What they're measuring
1
Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing
Timeframe: Within 30 minutes of start of study drug dosing.
. History of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
✕. History of allergic reaction to verapamil;
✕. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
✕. Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
✕. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval \<100 msec, Wolff Parkinson White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;
✕. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;