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Jan. 24, 2025 |
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June. 19, 2025 |
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jRCT2031240628 |
Phase II/III study of MD-712 |
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Phase II/III study of MD-712 |
Takahashi Kenta |
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Mochida Pharmaceutical Co., Ltd. |
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7, Yotsuya 1-chome, Shinjuku-ku, Tokyo |
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+81-3-3225-6332 |
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clinical.trials.contact@mochida.co.jp |
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Public relations |
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Mochida Pharmaceutical Co., Ltd. |
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7, Yotsuya 1-chome, Shinjuku-ku, Tokyo |
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+81-3-3225-6303 |
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webmaster@mochida.co.jp |
Not Recruiting |
Feb. 27, 2025 |
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| Feb. 27, 2025 | ||
| 15 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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Patient was diagnosed as either idiopathic or heritable PAH, drug- and toxin-induced PAH,CTD-PAH, HIV-PAH, CHD-PAH or PH associated with ILD or CPFE |
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Patient was diagnosed as PH other than those accepted as outlined in the Inclusion Criteria |
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| 18age old over | ||
| 80age old under | ||
Both |
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Pulmonary Arterial Hypertension and Pulmonary Hypertension associated with Interstitial Lung Disease |
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The initial dose of treprostinil should be set at one 16 mcg per treatment session, 4 times a day. |
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Rate of change in pulmonary vascular resistance index |
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Amount of change in 6-minute walk distance, etc |
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| Mochida Pharmaceutical Co., Ltd. |
| Keio University Hospital Institutional Review Board | |
| 35 Shinanomachi, Shinjuku-ku, Tokyo | |
+81-3-3353-1211 |
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| keio-chiken@adst.keio.ac.jp | |
| Approval | |
Dec. 27, 2024 |
No |
none |