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

NCT05326230 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

Interventions

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

DEVICE

Renal Angiogram

Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Sponsors & Collaborators

  • Otsuka Medical Devices Co., Ltd. Japan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-12-31
Completion
2032-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326230 on ClinicalTrials.gov