HypertensionPhase 3NCT01885390
Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
A Phase 3 study testing ROX COUPLER in people with Hypertension and Blood Pressure, High, run by ROX Medical, Inc. at 4 sites in 3 countries.
Trial summary
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Blood Pressure, High, Blood Pressure, Resistant
- What is being tested?
- ROX COUPLER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Mar 2014to 5 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.
Who cannot join
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
East Sussex Healthcare NHS Trust
Eastbourne, BN21 2UD
Queen Mary University of London
London, EC1M 6BQ
About this study
Official title: ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
- Conditions
- Hypertension, Blood Pressure, High, Blood Pressure, Resistant, Blood Pressure, Uncontrolled
- Being tested
- ROX COUPLER
- Keywords
- Hypertension, High blood pressure, Resistant blood pressure, Uncontrolled blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX COUPLERDevice
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group A | Experimental | ROX Coupler + continuing standard antihypertensive medications Receives: Device: ROX COUPLER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulatory daytime mean systolic blood pressure
Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
Measured: Baseline, 6 months
Secondary outcomes (1)
Change in ambulatory daytime mean diastolic blood pressure
Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start1 Mar 2014
- Primary completion5 May 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROX Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mel Lobo, MD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885390
- Sponsor's protocol ID
- RH-03
- Status last verified
- May 2019
- First submitted
- 20 Jun 2013
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT01885390
- Acronym / sponsor ID
- RH-03
- Conditions
- Hypertension, Blood Pressure, High, Blood Pressure, Resistant, Blood Pressure, Uncontrolled
- Keywords
- Hypertension, High blood pressure, Resistant blood pressure, Uncontrolled blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- ROX Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group A | Experimental | Device: ROX COUPLERROX Coupler + continuing standard antihypertensive medications |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.
Key exclusion criteria (1 listed)
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROX COUPLERThe COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein). | Device | Experimental: Group A |
Primary outcome
Change in ambulatory daytime mean systolic blood pressure
Time frame: Baseline, 6 months
Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
1 secondary outcome
Change in ambulatory daytime mean diastolic blood pressure
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mel Lobo, MD principal investigator
Queen Mary University of London
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ROX COUPLER in people with Hypertension and Blood Pressure, High, run by ROX Medical, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulatory daytime mean systolic blood pressure (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.