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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02250495




Registration number
NCT02250495
Ethics application status
Date submitted
20/09/2014
Date registered
26/09/2014
Date last updated
14/09/2015

Titles & IDs
Public title
The Sympara VIBE Study for Hypertension
Scientific title
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Secondary ID [1] 0 0
STS1402
Universal Trial Number (UTN)
Trial acronym
VIBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sympara Therapeutic System

Experimental: Sympara Therapeutic System - All subjects will wear for the Sympara device for 30 days


Treatment: Devices: Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Diabetes mellitus (Type 1)
* Chronic renal disease requiring dialysis
* Kidney or liver transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2016
Actual
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sympara Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, AM, PhD
Address 0 0
Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02250495