UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010355 |
|---|---|
| Receipt number | 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 09:10:06 |
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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
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
hiraik@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of clinical pharmacology and genetics, school of pharmaceutical science, university of Shizuoka graduate school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
