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 |
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Japan |
pulmonary hypertension
Cardiology |
Others
NO
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.
PK,PD
1. plasma drug concentration
2. laboratory tests
3. patients charactoristics
4. drug compliance
Observational
20 | years-old | <= |
Not applicable |
Male and Female
patients administered sildenafil, tadalafil, bosentan, ambrisentan and/or macitentan
patient who is decided as inadequate by doctor
50
1st name | |
Middle name | |
Last name | Hiroshi Watanabe |
Hamamatsu University School of Medicine
Department of Clinical Pharmacology and Therapeutics
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
053-435-2385
hwat@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Akio Hakamata |
Hamamatsu University School of Medicine
Department of Clinical Pharmacology and Therapeutics
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
053-435-2385
hakamata@hama-med.ac.jp
Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Self funding
Department of Parmacy Practice and Science, School of PharmaceuticalaScience, University of Shizuoka
NO
2016 | Year | 06 | Month | 03 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 07 | Month | 09 | Day |
2016 | Year | 06 | Month | 06 | Day |
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.
2016 | Year | 06 | Month | 03 | Day |
2016 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026045
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |