Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

NCT ID: NCT05463614

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Propafenone and Propranolol

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hebei province Children's Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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wei Zhao

Role: primary

0531-89268436

Other Identifiers

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2021_Cardiology Drugs_001

Identifier Type: -

Identifier Source: org_study_id

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