Population Pharmacokinetics of Propafenone and Propranolo... | NCT05463614

Studies
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

NCT05463614

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Jul 19, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Arrhythmia

Interventions

Propafenone and Propranolol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jul 8, 2022

First Submission Date that Met QC Criteria

Jul 17, 2022

First Posted Date

Jul 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2022

Last Update Posted Date

Jul 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propafenone and Propranolol	Drug	Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
P-R interval	P-R interval time	From date of randomization until the date of discharge, assessed up to 12 months
QT interval	QT interval time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children aged 0-18 years and receive treatment with Propafenone and Propranolol

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hebei province Children's Hospital	Recruiting	Shijiazhuang	Hebei		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011405	Propafenone
D011433	Propranolol

Ancestor Terms

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals
D050198	Phenoxypropanolamines

Browse Leaves

Not provided

Browse Branches

Not provided