Overview

This trial is active, not recruiting.

Condition hypertension
Treatment rox coupler
Phase phase 3
Sponsor ROX Medical, Inc.
Start date September 2012
End date December 2017
Trial size 100 participants
Trial identifier NCT01642498, RH-02

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ROX Coupler + continuing standard antihypertensive medications
rox coupler
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
(No Intervention)
Continuing standard antihypertensive medications

Primary Outcomes

Measure
Change in mean office SBP
time frame: Baseline, 6 months

Secondary Outcomes

Measure
Change in mean office DBP
time frame: Baseline, 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination Exclusion Criteria: - Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Additional Information

Official title ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by ROX Medical, Inc..