NCT06501638

Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats

Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats: a Multicenter Randomized Double-blind Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled study to expIore the efficacy and safety of Memantine hydrochIoride tabIets to treat patients with frequent PACs.

Detailed description

After preliminary screening, the target patients will undergo continuous 3-day (72-hour) monitoring with a wearable holter patch(as baseline data) to assess the number of baseline atrial premature beats. Based on the monitored data, it will be determined whether the subjects meet the inclusion criteria. Eligible participants will be randomly assigned in a 1:1 ratio (on Day 0) to either the experimental group (administered with hydrochloride memantine tablets) or the control group (placebo). A total of 256 subjects will be enrolled, with 128 subjects in each group, stratified by age (age ≥ 65 years vs. age \< 65 years) and the number of atrial premature beats (≥ 5000 beats/24h vs. \< 5000 beats/24h). The subjects in the experimental group will take hydrochloride memantine tablets according to the following regimen:Week 1: Half tablet per dose (5mg/dose), twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).Week 2 to Week 6: One tablet per dose (10mg/dose), twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours). Control group (placebo): The subjects in the control group will take placebo according to the following regimen:Week 1: Half tablet per dose, twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).Week 2 to Week 6: One tablet per dose, twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours). The study consists of a screening period (D0-D7 days), a treatment period (D8-D42 days), and a follow-up period (D43-D56 days).The start dates for the 3-day ambulatory holter patch are as follows: D25-D28, D39-D42, and D53-D56.

Conditions

• Atrial Premature Beats, Contractions, or Systoles

Interventions

Type	Name	Description
DRUG	Memantine Hydrochloride 10 MG	Take Memantine Hydrochloride for intervention First week, 5mg(half the tablet), p.o.，bid. Second to Sixth week, 10mg(one tablet), p.o., bid
DRUG	Placebo	Take placebo for intervention First week, half the tablet, p.o., bid. Second to Sixth week, one tablet, p.o., bid

Timeline

• Start date: 2024-08-29
• Primary completion: 2025-03-21
• Completion: 2025-05-16
• First posted: 2024-07-15
• Last updated: 2025-11-25

Locations

1 site across 1 country: China