Feb. 19, 2022 |
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July. 16, 2024 |
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jRCT2051210177 |
Phase IIb/III Clinical Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy |
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Phase IIb/III Clinical Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy |
Akita Yasuhiko |
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TOA EIYO LTD. |
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3-10-6, Hatchobori, Chuo-ku, TOKYO |
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+81-3-6757-1040 |
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ct_info@toaeiyo.co.jp |
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Clinical Development Dept. |
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TOA EIYO LTD. |
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3-10-6, Hatchobori, Chuo-ku, TOKYO |
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+81-3-6757-1040 |
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ct_info@toaeiyo.co.jp |
Not Recruiting |
Feb. 19, 2022 |
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Mar. 03, 2022 | ||
60 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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Patients with a confirmed diagnosis of idiopathic TGCV and who are least 18 years of age at time of informed consent. |
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Patients with NYHA functional class I and both TGCV severity score ADL and symptom score of less than 10 points at the Baseline Visit. |
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18age old over | ||
No limit | ||
Both |
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Idiopathic triglyceride deposit cardiomyovasculopathy |
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CNT-01 or CNT-01 placebo is administered orally three times daily (in the morning, at noon, and in the evening). The starting dose of CNT-01 is 500 mg (1,500 mg/day) for the first 2 weeks, then the dose is increased to 1000 mg (3,000 mg/day). |
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major adverse cardiovascular events |
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Change from Baseline Visit in BMIPP WR. |
TOA EIYO LTD. |
Institutional Review Board of Osaka University Hospital | |
2-15 Yamadaoka, Suita,, Osaka | |
+81-6-6210-8290 |
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jim-chiken@hp-crc.med.osaka-u.ac.jp | |
Approval | |
Feb. 01, 2022 |
No |
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none |