HypertensionPhase 1/2VIBENCT02250495
The Sympara VIBE Study for Hypertension
A Phase 1/2 study testing Sympara Therapeutic System in people with Hypertension, run by Sympara Medical, Inc. at 3 sites in Australia.
Trial summary
The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Sympara Therapeutic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesAustralia
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
- Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
- Minimum six- (6) month history of diagnosis and treatment of hypertension
Who cannot join
- Previous renal denervation or carotid barostimulation implant
- Secondary causes of hypertension or primary pulmonary hypertension
- Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
- Known or suspected baroreflex failure or significant orthostatic hypotension
- One or more hospital admissions for a hypertensive crisis within the past year
- History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
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- Diabetes mellitus (Type 1)
- Chronic renal disease requiring dialysis
- Kidney or liver transplant
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Monash Health
Clayton, Victoria, 3168
Barwon Health
Geelong, Victoria, 3220
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension
- Conditions
- Hypertension
- Being tested
- Sympara Therapeutic System
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympara Therapeutic SystemDevice
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
| Study group | Role | What they receive |
|---|---|---|
| Sympara Therapeutic System | Experimental | All subjects will wear for the Sympara device for 30 days Receives: Device: Sympara Therapeutic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Measured: 30 days
Secondary outcomes (1)
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Company closed
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sympara Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Meredith, AM, PhD, Principal investigator, Monash Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250495
- Sponsor's protocol ID
- STS1402
- Acronym
- VIBE
- Status last verified
- Sep 2015
- First submitted
- 20 Sep 2014
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT02250495
- Acronym / sponsor ID
- VIBE / STS1402
- Conditions
- Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company closed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sympara Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 26 Sep 2014 (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 the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sympara Therapeutic System | Experimental | Device: Sympara Therapeutic SystemAll subjects will wear for the Sympara device for 30 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
- Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
- Minimum six- (6) month history of diagnosis and treatment of hypertension
Key exclusion criteria (9 listed)
- Previous renal denervation or carotid barostimulation implant
- Secondary causes of hypertension or primary pulmonary hypertension
- Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
- Known or suspected baroreflex failure or significant orthostatic hypotension
- One or more hospital admissions for a hypertensive crisis within the past year
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 |
|---|---|---|
| Sympara Therapeutic SystemSympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension | Device | Sympara Therapeutic System |
Primary outcome
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Time frame: 30 days
1 secondary outcome
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Company closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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.
Ian Meredith, AM, PhD principal investigator
Monash Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sympara Therapeutic System in people with Hypertension, run by Sympara Medical, Inc. at 3 sites in Australia.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Company closed). Results are not available in the source record.
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?
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability (time frame: 30 days). 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 14 Sep 2015.