A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

April 10, 2026 updated by: Otsuka Medical Devices Co., Ltd. Japan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aomori
      • Hirosaki-shi, Aomori, Japan
        • Hirosaki University Hospital
    • Chiba
      • Urayasu-shi, Chiba, Japan
        • Tokyo Bay Urayasu Ichikawa Medical Center
    • Ehime
      • Toon-shi, Ehime, Japan
        • Ehime University Hospital
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Fukuoka, Japan
        • Kyushu University Hospital
      • Fukuoka, Fukuoka, Japan
        • Fukuoka Sanno Hospital
      • Kurume-shi, Fukuoka, Japan
        • Kurume University Hospital
    • Fukushima
      • Iwaki, Fukushima, Japan
        • Iwaki City Medical Center
    • Gifu
      • Seki-shi, Gifu, Japan
        • Chuno Kousei Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Hiroshima City North Medical Center Asa Citizens Hospital
    • Hokkaido
      • Nayoro-shi, Hokkaido, Japan
        • Nayoro City General Hospital
      • Sapporo, Hokkaido, Japan
        • Sapporo-Kosei General Hospital
      • Sapporo, Hokkaido, Japan
        • Tonan Hospital
      • Tomakomai-shi, Hokkaido, Japan
        • Tomakomai City Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Kobe University Hospital
      • Nishinomiya-Shi, Hyōgo, Japan
        • Nishinomiya Municipal Central Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan
        • Kanazawa University Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan
        • Kagoshima University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan
        • Yokohama Rosai Hospital
      • Yokohama, Kanagawa, Japan
        • Saiseikai Yokohamashi Nanbu Hospital
    • Kochi
      • Kochi, Kochi, Japan
        • Chikamori Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan
        • Kumamoto University Hospital
      • Kumamoto, Kumamoto, Japan
        • Japanese Red Cross Kumamoto Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan
        • University Hospital Kyoto Prefectural University of Medicine
    • Mie-ken
      • Suzuka-Shi, Mie-ken, Japan
        • Suzuka Chuo General Hospital
    • Miyagi
      • Sendai, Miyagi, Japan
        • Tohoku University Hospital
    • Miyazaki
      • Miyazaki, Miyazaki, Japan
        • Miyazaki Medical Association Hospital
    • Niigata
      • Niigata, Niigata, Japan
        • Niigata City General Hospital
    • Okayama-ken
      • Okayama, Okayama-ken, Japan
        • Okayama Rosai Hospital
    • Okinawa
      • Naha, Okinawa, Japan
        • Ryukyu University Hospital
    • Osaka
      • Osaka, Osaka, Japan
        • Osaka Saiseikai Nakatsu Hospital
      • Sakai-shi, Osaka, Japan
        • Osaka Rosai Hospital
      • Suita-shi, Osaka, Japan
        • Osaka University Hospital
      • Suita-shi, Osaka, Japan
        • National Cerebral and Cardiovascular Center
    • Saga-ken
      • Tosu-shi, Saga-ken, Japan
        • Imamura Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Hamamatsu University Hospital
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan
        • Jichi Medical University Hospital
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan
        • Mitsui Memorial Hospital
      • Cyuo-ku, Tokyo, Japan
        • St. Luke's International Hospital
      • Hachioji-shi, Tokyo, Japan
        • Minamino Junkanki Hospital
      • Meguro-Ku, Tokyo, Japan
        • Kimura Clinic
      • Meguro-ku, Tokyo, Japan
        • Toho University Medical Center Ohashi Hospital
      • Minato-ku, Tokyo, Japan
        • Tokyo Saiseikai Central Hospital
      • Minato-ku, Tokyo, Japan
        • Toranomon Hospital
      • Minato-ku, Tokyo, Japan
        • Tokyo Takanawa Hospital
      • Musashino-shi, Tokyo, Japan
        • Japanese Red Cross Musashino Hospital
      • Setagaya-ku, Tokyo, Japan
        • Nissan Tamagawa Hospital
      • Ōta-ku, Tokyo, Japan
        • Tokyo Rosai Hospital
    • Tottori
      • Yonago-shi, Tottori, Japan
        • Sanin Rosai Hospital
    • Yamagata
      • Sakata-shi, Yamagata, Japan
        • Nihonkai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria :

  • 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

Exclusion Criteria

  • Lacks appropriate renal artery anatomy for renal denervation
  • Secondary hypertension other than sleep apnea
  • Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
  • Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
  • Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
  • Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
  • Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
  • Patients with a history of persistent or permanent atrial tachyarrhythmia
  • Patients with active implantable medical devices
  • Primary pulmonary hypertension
  • Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
  • Night shift workers
  • Pregnant, nursing or planning to become pregnant

  • Patients with any of the following central laboratory tests at screening

    • Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
    • HbA1c greater than or equal to 8.0%
    • eGFR less than 40 mL/min/1.73m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Control
Renal Angiogram
Device: Renal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Device: 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
Other Names:
  • Renal Angiogram/Renal Denervation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change in 24-hour systolic ABPM
Time Frame: From baseline to 3 months post-procedure
From baseline to 3 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean change in 24-hour systolic ABPM
Time Frame: from baseline to 6 months post-procedure
from baseline to 6 months post-procedure
Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
Time Frame: From baseline to 3, 6, 12 months post-procedure
From baseline to 3, 6, 12 months post-procedure
Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time Frame: 3, 6, and 12months post-procedure
3, 6, and 12months post-procedure
Percentage of subjects who required a change in antihypertensive medication
Time Frame: at any time up to 12 months after the procedure
at any time up to 12 months after the procedure
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Time Frame: 3, 6, 12 months after the procedure
3, 6, 12 months after the procedure
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Time Frame: 3, 6, 12 months after the procedure
3, 6, 12 months after the procedure
Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
Time Frame: 3, 6, 12 months after the procedure
3, 6, 12 months after the procedure
Change in mean heart rate in the office, home, ABPM
Time Frame: 3, 6, 12 months after the procedure
3, 6, 12 months after the procedure
Change in mean sitting office blood pressure (systolic/diastolic)
Time Frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure
From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure
Change in mean home blood pressure (systolic/diastolic)
Time Frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure
From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Medical Devices Co., Ltd. Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RDN-21-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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