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Japanese

Jan. 24, 2025

June. 19, 2025

jRCT2031240628

Phase II/III study of MD-712

Phase II/III study of MD-712

Takahashi Kenta

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6332

clinical.trials.contact@mochida.co.jp

Public relations

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6303

webmaster@mochida.co.jp

Not Recruiting

Feb. 27, 2025

Feb. 27, 2025
15

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Patient was diagnosed as PH other than those accepted as outlined in the Inclusion Criteria

18age old over
80age old under

Both

Pulmonary Arterial Hypertension and Pulmonary Hypertension associated with Interstitial Lung Disease

The initial dose of treprostinil should be set at one 16 mcg per treatment session, 4 times a day.
If tolerated, the dose can be gradually increased up to 64 mcg and maintained.

Rate of change in pulmonary vascular resistance index

Amount of change in 6-minute walk distance, etc

Mochida Pharmaceutical Co., Ltd.
Keio University Hospital Institutional Review Board
35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-3353-1211

keio-chiken@adst.keio.ac.jp
Approval

Dec. 27, 2024

No

none

History of Changes

No Publication date
4 June. 19, 2025 (this page) Changes
3 Mar. 07, 2025 Detail Changes
2 Feb. 07, 2025 Detail Changes
1 Jan. 24, 2025 Detail