NCT01642498 is a Phase 3 clinical trial of ROX COUPLER in Hypertension, sponsored by ROX Medical, Inc..

Who is sponsoring NCT01642498?

NCT01642498 is sponsored by ROX Medical, Inc..

What drugs are being tested in NCT01642498?

Interventions in NCT01642498: ROX COUPLER.

What condition does NCT01642498 study?

NCT01642498 studies Hypertension.

Is NCT01642498 still recruiting?

NCT01642498 is currently completed. Last updated 10 May 2019.

Last reviewed 2019-05-10 · How we verify

NCT01642498

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

A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

Completed Phase 3 Last updated 10 May 2019

What this trial tests

Phase 3 trial testing ROX COUPLER in Hypertension in 100 participants. Completed in 30 June 2018.

Timeline

1 September 2012

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	ROX Medical, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 September 2012
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	18 locations across Netherlands, Greece, Belgium, Ireland, United Kingdom, Germany, Poland

Drugs / interventions tested

ROX COUPLER

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

ROX Medical, Inc.

Who can join

Adults 18 to 80, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

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

Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial.
Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, et al · · 2015 · cited 113× · PMID 25620016 · DOI 10.1016/s0140-6736(14)62053-5
Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial.
Lobo MD, Ott C, Sobotka PA, Saxena M, et al · · 2017 · cited 36× · PMID 29061728 · DOI 10.1161/hypertensionaha.117.10142
Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.
Ott C, Lobo MD, Sobotka PA, Mahfoud F, et al · · 2016 · cited 21× · PMID 28003251 · DOI 10.1161/jaha.116.004234
Advances in Ventilator Management for Patients with Acute Respiratory Distress Syndrome.
Sklar MC, Munshi L. · · 2022 · cited 6× · PMID 36116817 · DOI 10.1016/j.ccm.2022.05.002

Verify or expand the search:

Other trials of ROX COUPLER

Trials testing the same drug.

NCT01885390 — Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled 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
NCT01885390 — Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled 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 NCT01642498 (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: 10 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/NCT01642498.

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