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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010355
Receipt No. R000012107
Scientific Title A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients
Date of disclosure of the study information 2013/04/01
Last modified on 2018/09/04

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Basic information
Public title A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients
Acronym A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients
Scientific Title A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients
Scientific Title:Acronym A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients
Region
Japan

Condition
Condition Pulmonary arterial hypertension
Classification by specialty
Cardiology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study assesses the relationship between individual polymorphism and each result of PK/PD analysis based on maintenance dose, pharmacokinetics, efficacy, and safety in pediatric patients taking medicine for pulmonary arterial hypertension.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess PK/PD based on plasma concentration of PAH medicines, as well as efficacy and safety in PAH pediatric patients.
Key secondary outcomes To explore gene polymorphisms relating to pharmacokinetics, efficacy, and safety of PAH medicines.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
0 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1. PAH patients <20 years of age

2. Patients taking PAH medicines (Endothelin receptor antagonist, PDE5 inhibitor, oral prostanoid)

3. Signed informed consent prior to blood sampling for this study.
Key exclusion criteria No exclusion criteria
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Hirai
Organization Shizuoka children's hospital
Division name Pharmaceutical department
Zip code
Address 860 Urushiyama Aoi-ku Shizuoka-city Shizuoka Japan
TEL 054-247-6251
Email hirai.kt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keita Hirai
Organization University of Shizuoka
Division name Department of clinical pharmacology and genetics
Zip code
Address 52-1 Yada Suruga-ku Shizuoka-city Shizuoka Japan
TEL 054-264-5674
Homepage URL
Email hiraik@u-shizuoka-ken.ac.jp

Sponsor
Institute Department of clinical pharmacology and genetics, school of pharmaceutical science, university of Shizuoka graduate school
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Shizuoka children's hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationship between the blood concentration of PAH treatment and the efficacy/safety.
Relationship between the PK/PD of PAH treatment and polymorphism.

Management information
Registered date
2013 Year 03 Month 29 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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