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Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05463614
Enrollment
500
Registered
2022-07-19
Start date
2019-02-01
Completion date
2025-12-01
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Brief 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.

Interventions

DRUGPropafenone and Propranolol

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

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventricular premature beats of 24 hoursFrom date of randomization until the date of discharge, assessed up to 12 monthsfrequency of Ventricular premature beats of 24 hours

Secondary

MeasureTime frameDescription
P-R intervalFrom date of randomization until the date of discharge, assessed up to 12 monthsP-R interval time
QT intervalFrom date of randomization until the date of discharge, assessed up to 12 monthsQT interval time

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026