April. 16, 2022 |
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Mar. 15, 2024 |
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jRCT2032220027 |
A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertension (RADIANCE-HTN DUO) |
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A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertension (RADIANCE-HTN DUO) |
Kai Hisashi |
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Kurume University Medical Center |
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155-1, Kokubu-machi, Kurume-shi, Fukuoka |
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+81-3-6361-7459 |
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OtsukaRegistry-CT@otsuka.jp |
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Haraguchi Mikiko |
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Otsuka Medical Devices Co., Ltd. |
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Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-0075, Japan |
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+81-3-6361-7459 |
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OtsukaRegistry-CT@otsuka.jp |
Recruiting |
April. 01, 2022 |
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July. 13, 2022 | ||
154 | ||
Interventional |
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randomized controlled trial |
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double blind |
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no treatment control/standard of care control |
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parallel assignment |
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treatment purpose |
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1. Patients who have received antihypertensive treatment with two antihypertensive drugs for at least 4 weeks prior to obtaining consent, with no change in the type or dosage |
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1. Lacks appropriate renal artery anatomy for renal denervation |
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20age old over | ||
75age old under | ||
Both |
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Hypertension |
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Renal denervation |
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Primary endpoint: Mean change in 24-hour systolic ABPM from baseline to 3 months post-procedure |
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- Important secondary endpoint |
Otsuka Medical Devices Co., Ltd. |
IHWG-IRB | |
3-6-45, momochihama,soura-ku, Fukuoka-shi, Fukuoka, Fukuoka | |
+81-92-832-1100 |
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Approval | |
No |
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NCT05326230 | |
ClinicalTrial.gov |
none |