A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Mean change in 24-hour systolic ABPM — From baseline to 3 months post-procedure
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| Hirosaki University Hospital | Hirosaki-shi | Aomori | |
| Tokyo Bay Urayasu Ichikawa Medical Center | Urayasu-shi | Chiba | |
| Ehime University Hospital | Toon-shi | Ehime | |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | |
| Fukuoka Sanno Hospital | Fukuoka | Fukuoka | |
| Kyushu University Hospital | Fukuoka | Fukuoka | |
| Kurume University Hospital | Kurume-shi | Fukuoka | |
| Iwaki City Medical Center | Iwaki | Fukushima | |
| Chuno Kousei Hospital | Seki-shi | Gifu | |
| Hiroshima City North Medical Center Asa Citizens Hospital | Hiroshima | Hiroshima | |
| Nayoro City General Hospital | Nayoro-shi | Hokkaido | |
| Sapporo-Kosei General Hospital | Sapporo | Hokkaido | |
| Tonan Hospital | Sapporo | Hokkaido | |
| Tomakomai City Hospital | Tomakomai-shi | Hokkaido | |
| Kobe University Hospital | Kobe | Hyōgo | |
| Nishinomiya Municipal Central Hospital | Nishinomiya-Shi | Hyōgo | |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | |
| Kagoshima University Hospital | Kagoshima | Kagoshima-ken | |
| Saiseikai Yokohamashi Nanbu Hospital | Yokohama | Kanagawa | |
| Yokohama City University Hospital | Yokohama | Kanagawa | |
| Yokohama Rosai Hospital | Yokohama | Kanagawa | |
| Chikamori Hospital | Kochi | Kochi | |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | |
| Kumamoto University Hospital | Kumamoto | Kumamoto | |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | |
| Suzuka Chuo General Hospital | Suzuka-Shi | Mie-ken | |
| Tohoku University Hospital | Sendai | Miyagi | |
| Miyazaki Medical Association Hospital | Miyazaki | Miyazaki | |
| Niigata City General Hospital | Niigata | Niigata | |
| Okayama Rosai Hospital | Okayama | Okayama-ken | |
| Ryukyu University Hospital | Naha | Okinawa | |
| Osaka Saiseikai Nakatsu Hospital | Osaka | Osaka | |
| Osaka Rosai Hospital | Sakai-shi | Osaka | |
| National Cerebral and Cardiovascular Center | Suita-shi | Osaka | |
| Osaka University Hospital | Suita-shi | Osaka | |
| Imamura Hospital | Tosu-shi | Saga-ken | |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | |
| Jichi Medical University Hospital | Shimotsuke-shi | Tochigi | |
| Mitsui Memorial Hospital | Chiyoda-ku | Tokyo | |
| St. Luke's International Hospital | Cyuo-ku | Tokyo |
+ 11 more sites — see the full list on the official registry below.
More Otsuka Medical Devices Co., Ltd. Japan trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05326230 on ClinicalTrials.gov ↗ ← All trials in Japan