Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00442286 · ClinicalTrials.gov registry record · NA
Rheos® Pivotal Trial
A NA study, sponsored by CVRx.
- Completed
- Registry status
- NA
- Development phase
- 591
- Enrollment target
NCT00442286: Completed NA study, sponsored by CVRx.
NCT00442286 is a NA study that has completed, run by CVRx. The registered enrollment target is 591 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00442286, a NA study, has completed, sponsored by CVRx.
- COMPLETED
- Registry status
- NA
- Development phase
- 591 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.
Primary Outcome
Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.
Interventions
- DEVICE Rheos® Baroreflex Hypertension System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 591 participants |
| Start Date | 2006-10 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT00442286 record still lists
NCT00442286 is an interventional study that assigns participants to a tested intervention. The registered 591 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Rheos® Baroreflex Hypertension System is the first listed.
NCT00442286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00442286 about?
NCT00442286 is a clinical study titled "Rheos® Pivotal Trial". The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.
What is the current status of trial NCT00442286?
This trial is currently completed. It is a NA study. The enrollment target is 591 participants. The study started on 2006-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00442286?
The interventions under investigation include: Rheos® Baroreflex Hypertension System (DEVICE).
Who is sponsoring clinical trial NCT00442286?
This trial is sponsored by CVRx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00442286's enrollment target sits among peer trials
591 175th of 2000 higher than 1,826 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01365169 · 590 participants · NA
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
- NCT03774758 · 590 participants
Biomarkers for Risk Stratification in Lung Cancer
- NCT04747626 · 590 participants · NA
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
- NCT05722938 · 590 participants · Phase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia