Unique ID issued by UMIN | UMIN000005464 |
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Receipt number | R000006480 |
Scientific Title | Drug interactions and effects of combination therapy for pulmonary arterial hypertension |
Date of disclosure of the study information | 2011/04/19 |
Last modified on | 2011/04/18 23:14:14 |
Drug interactions and effects of combination therapy for pulmonary arterial hypertension
Drug interactions and effects of PAH combination therapy
Drug interactions and effects of combination therapy for pulmonary arterial hypertension
Drug interactions and effects of PAH combination therapy
Japan |
pulmonary arterial hypertension
Medicine in general | Cardiology | Pneumology |
Others
NO
To evaluate the drug interactions and effects of combination therapy for pulmonary arterial hypertension; sildenafil and bosentan, sildenafil and ambrisentan, and tadalafil and ambrisentan.
Efficacy
Confirmatory
Pragmatic
Not applicable
Pharmacokinetics in the last week of each phase: sildenafil, bosentan, ambrisentan and tadalafil.
Exercise tolerability test: 6 minute walk test, shattle walking test and maximal oxygen consumption test.
Interventional
Factorial
Non-randomized
Open -no one is blinded
Uncontrolled
3
Treatment
Medicine |
phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks
phase 2: sildenafil(60mg/day) and
ambrisentan (5mg/day) for 4 or 5 weeks
phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Males or females over 20 years of age with pulmonary arterial hypertension in WHO functional classes I or II.
No history of drug allergy.
No history of drug and alchohol abuse.
Written informed concent obtained.
Unstable disease conditions.
Disabilities of walk.
Home oxygen therapy.
Ineligible patients judged by principal. investigator.
15
1st name | |
Middle name | |
Last name | Kazuhiko Takeuchi |
Hamamatsu University School of Medicine
Clinical Pharmacology and Therapeutics
1-20-1 Handayama Higashi-ku Hamamatsu Japan
053-435-2385
1st name | |
Middle name | |
Last name | Kazuhiko Takeuchi |
Hamamatsu University School of Medicine
Clinical Pharmacology and Therapeutics
1-20-1 Handayama Higashi-ku Hamamatsu Japan
053-435-2385
takeutik@hama-med.ac.jp
Hamamatsu University School of Medicine
Hamamatsu University School of Medicine
Other
Japan
University of Shizuoka
NO
浜松医科大学付属病院(静岡県)
2011 | Year | 04 | Month | 19 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 18 | Day |
2011 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006480
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