NCT01885390 is a Phase 3 clinical trial of ROX COUPLER in Hypertension, sponsored by ROX Medical, Inc..

Who is sponsoring NCT01885390?

NCT01885390 is sponsored by ROX Medical, Inc..

What drugs are being tested in NCT01885390?

Interventions in NCT01885390: ROX COUPLER.

What condition does NCT01885390 study?

NCT01885390 studies Hypertension, Blood Pressure, High, Blood Pressure, Resistant, Blood Pressure, Uncontrolled.

Is NCT01885390 still recruiting?

NCT01885390 is currently completed. Last updated 13 May 2019.

Last reviewed 2019-05-13 · How we verify

NCT01885390

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

Completed Phase 3 Last updated 13 May 2019

What this trial tests

Phase 3 trial testing ROX COUPLER in Hypertension in 83 participants. Completed in 5 May 2019.

Timeline

1 March 2014

Primary endpoint
5 May 2019

5 May 2019

Quick facts

Lead sponsor	ROX Medical, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	1 March 2014
Primary completion	5 May 2019
Estimated completion	5 May 2019
Sites	4 locations across Belgium, United Kingdom, Netherlands

Drugs / interventions tested

ROX COUPLER

Conditions studied

Hypertension — all drugs for Hypertension →
Blood Pressure, High — all drugs for Blood Pressure, High →
Blood Pressure, Resistant — all drugs for Blood Pressure, Resistant →
Blood Pressure, Uncontrolled — all drugs for Blood Pressure, Uncontrolled →

Sponsor

ROX Medical, Inc.

Who can join

Adults 18 to 85, any sex, with Hypertension or Blood Pressure, High. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Central iliac arteriovenous anastomosis for hypertension: targeting mechanical aspects of the circulation.
Kapil V, Sobotka PA, Saxena M, Mathur A, et al · · 2015 · cited 12× · PMID 26228235 · DOI 10.1007/s11906-015-0585-6
The hemodynamic effects of a central iliac arteriovenous anastomosis at 6 months in patients with resistant and uncontrolled hypertension.
Eysenck W, van Zalen J, Freemantle N, Lloyd G, et al · · 2019 · cited 2× · PMID 31347773 · DOI 10.1111/jch.13646

Verify or expand the search:

Other trials of ROX COUPLER

Trials testing the same drug.

NCT01642498 — A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension · Phase 3 · completed

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Other ROX Medical, Inc. trials

Trials by the same sponsor.

NCT02895386 — A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension · NA · terminated
NCT01642498 — A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01885390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ROX Medical, Inc.
Last refreshed: 13 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01885390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing