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A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
Sponsor: Otsuka Medical Devices Co., Ltd. Japan
Summary
To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.
Official title: A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension
Key Details
Gender
All
Age Range
20 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2022-07-01
Completion Date
2032-12
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Renal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Locations (51)
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Iwaki City Medical Center
Iwaki, Fukushima, Japan
Chuno Kousei Hospital
Seki-shi, Gifu, Japan
Hiroshima City North Medical Center Asa Citizens Hospital
Hiroshima, Hiroshima, Japan
Nayoro City General Hospital
Nayoro-shi, Hokkaido, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Tonan Hospital
Sapporo, Hokkaido, Japan
Tomakomai City Hospital
Tomakomai-shi, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya-Shi, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan
Chikamori Hospital
Kochi, Kochi, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Suzuka Chuo General Hospital
Suzuka-Shi, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, Japan
Niigata City General Hospital
Niigata, Niigata, Japan
Okayama Rosai Hospital
Okayama, Okayama-ken, Japan
Ryukyu University Hospital
Naha, Okinawa, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, Japan
Osaka Rosai Hospital
Sakai-shi, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Imamura Hospital
Tosu-shi, Saga-ken, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan
St. Luke's International Hospital
Cyuo-ku, Tokyo, Japan
Minamino Junkanki Hospital
Hachioji-shi, Tokyo, Japan
Kimura Clinic
Meguro-Ku, Tokyo, Japan
Toho University Medical Center Ohashi Hospital
Meguro-ku, Tokyo, Japan
Tokyo Saiseikai Central Hospital
Minato-ku, Tokyo, Japan
Tokyo Takanawa Hospital
Minato-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan
Tokyo Rosai Hospital
Ōta-ku, Tokyo, Japan
Nissan Tamagawa Hospital
Setagaya-ku, Tokyo, Japan
Sanin Rosai Hospital
Yonago-shi, Tottori, Japan
Nihonkai General Hospital
Sakata-shi, Yamagata, Japan