Trials / Active Not Recruiting
Active Not RecruitingNCT05326230
A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2026-12-01
- Completion
- 2032-12-01
- First posted
- 2022-04-13
- Last updated
- 2026-04-15
Locations
51 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05326230. Inclusion in this directory is not an endorsement.