Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Arrhythmia Clinical Trial

Official title:

Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463614
• Other study ID #: 2021_Cardiology Drugs_001
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2022
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Patients aged =18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol

Exclusion Criteria:

• Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Drug:
• Propafenone and Propranolol
Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day

Locations

Country	Name	City	State
China	Hebei province Children's Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular premature beats of 24 hours	frequency of Ventricular premature beats of 24 hours	From date of randomization until the date of discharge, assessed up to 12 months
Secondary	P-R interval	P-R interval time	From date of randomization until the date of discharge, assessed up to 12 months
Secondary	QT interval	QT interval time	From date of randomization until the date of discharge, assessed up to 12 months