UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022593 |
|---|---|
| Receipt number | R000026045 |
| Scientific Title | Comfirmation of therapeutic drug monitoring for pulmonary hypertension |
| Date of disclosure of the study information | 2016/06/03 |
| Last modified on | 2016/09/21 07:43:15 |
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Basic information
Public title
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Acronym
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Scientific Title
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Scientific Title:Acronym
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the development of therapeutic drug monitoring (TDM) of PAH drugs (sildenafil, tadalafil, bosentan, macitentan, ambrisentan), and to perform population pharmacokinetic analysis.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. plasma drug concentration
2. laboratory tests
3. patients charactoristics
4. drug compliance
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients administered sildenafil, tadalafil, bosentan, ambrisentan and/or macitentan
Key exclusion criteria
patient who is decided as inadequate by doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Hakamata |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
hakamata@hama-med.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Parmacy Practice and Science, School of PharmaceuticalaScience, University of Shizuoka
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
| 2016 | Year | 06 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples are taken from patients who are treated with sildenafil, tadalafil, bosentan, ambrisentan, macitentan at 1-3 points per day. Administration of drugs and laboratory tests are not changed from the needs of therapy.
Plasma drug concentration, values of laboratory test, patients charactoristics and drug compliane are investigated.
Pharmacokinetic analysis and evaluation of relationship between plasna concentrations and efficacy/safety are performed.
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2016 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026045
