Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05463614
Collaborator
(none)
500
1
82
6.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Actual Study Start Date
:
Feb 1, 2019
Anticipated Primary Completion Date
:
Aug 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2025
Outcome Measures
Primary Outcome Measures
- Ventricular premature beats of 24 hours [From date of randomization until the date of discharge, assessed up to 12 months]
frequency of Ventricular premature beats of 24 hours
Secondary Outcome Measures
- P-R interval [From date of randomization until the date of discharge, assessed up to 12 months]
P-R interval time
- QT interval [From date of randomization until the date of discharge, assessed up to 12 months]
QT interval time
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 18 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei province Children's Hospital | Shijiazhuang | Hebei | China |
Sponsors and Collaborators
- Shandong University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wei Zhao,
professor,
Shandong University
ClinicalTrials.gov Identifier:
NCT05463614
Other Study ID Numbers:
- 2021_Cardiology Drugs_001
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: