A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.

• Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.

• Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit

Locations
Other Locations
Japan
Fukuoka University Chikushi Hospital
TERMINATED
Chikushino-shi
Mitsui Memorial Hospital
RECRUITING
Chiyoda-ku
St. Luke's International Hospital
RECRUITING
Cyuo-ku
Fukuoka Sanno Hospital
RECRUITING
Fukuoka
Kyushu University Hospital
RECRUITING
Fukuoka
Minamino Junkanki Hospital
TERMINATED
Hachioji-shi
Hamamatsu University Hospital
TERMINATED
Hamamatsu
Hirosaki University Hospital
TERMINATED
Hirosaki-shi
Hiroshima City North Medical Center Asa Citizens Hospital
TERMINATED
Hiroshima
Iwaki City Medical Center
TERMINATED
Iwaki
Kagoshima University Hospital
RECRUITING
Kagoshima
Kanazawa University Hospital
TERMINATED
Kanazawa
Kobe University Hospital
RECRUITING
Kobe
Chikamori Hospital
RECRUITING
Kochi
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Kumamoto University Hospital
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume-shi
University Hospital Kyoto Prefectural University of Medicine
TERMINATED
Kyoto
Kimura Clinic
TERMINATED
Meguro-ku
Toho University Medical Center Ohashi Hospital
RECRUITING
Meguro-ku
Tokyo Saiseikai Central Hospital
RECRUITING
Minato-ku
Tokyo Takanawa Hospital
TERMINATED
Minato-ku
Toranomon Hospital
TERMINATED
Minato-ku
Miyazaki Medical Association Hospital
RECRUITING
Miyazaki
Japanese Red Cross Musashino Hospital
TERMINATED
Musashino-shi
Ryukyu University Hospital
RECRUITING
Naha
Nayoro City General Hospital
TERMINATED
Nayoro-shi
Niigata City General Hospital
RECRUITING
Niigata
Nishinomiya Municipal Central Hospital
RECRUITING
Nishinomiya-shi
Okayama Rosai Hospital
RECRUITING
Okayama
Osaka Saiseikai Nakatsu Hospital
TERMINATED
Osaka
Tokyo Rosai Hospital
TERMINATED
Ōta-ku
Osaka Rosai Hospital
RECRUITING
Sakai-shi
Nihonkai General Hospital
RECRUITING
Sakata-shi
Sapporo-Kosei General Hospital
RECRUITING
Sapporo
Tonan Hospital
RECRUITING
Sapporo
Chuno Kousei Hospital
TERMINATED
Seki-shi
Tohoku University Hospital
TERMINATED
Sendai
Nissan Tamagawa Hospital
TERMINATED
Setagaya-ku
Jichi Medical University Hospital
RECRUITING
Shimotsuke-shi
National Cerebral and Cardiovascular Center
RECRUITING
Suita-shi
Osaka University Hospital
RECRUITING
Suita-shi
Suzuka Chuo General Hospital
RECRUITING
Suzuka-shi
Tomakomai City Hospital
TERMINATED
Tomakomai-shi
Ehime University Hospital
TERMINATED
Toon-shi
Imamura Hospital
RECRUITING
Tosu-shi
Tokyo Bay Urayasu Ichikawa Medical Center
RECRUITING
Urayasu-shi
Saiseikai Yokohamashi Nanbu Hospital
TERMINATED
Yokohama
Yokohama City University Hospital
RECRUITING
Yokohama
Yokohama Rosai Hospital
RECRUITING
Yokohama
Sanin Rosai Hospital
RECRUITING
Yonago-shi
Contact Information
Primary
Kentaro Ishinabe
OtsukaRegistry-CT@otsuka.jp
+81 3 6361 7459
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2032-12
Participants
Target number of participants: 154
Treatments
Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Sham_comparator: Sham Control
Renal Angiogram
Related Therapeutic Areas
Sponsors
Leads: Otsuka Medical Devices Co., Ltd. Japan

This content was sourced from clinicaltrials.gov