The Sympara VIBE Study for Hypertension (VIBE)

September 11, 2015 updated by: Sympara Medical, Inc.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Geelong, Victoria, Australia, 3220
        • Barwon Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sympara Therapeutic System
All subjects will wear for the Sympara device for 30 days
Device: Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sympara Medical, Inc.

Investigators

  • Principal Investigator: Ian Meredith, AM, PhD, Monash Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STS1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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