Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2014-10-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sympara Therapeutic System
All subjects will wear for the Sympara device for 30 days
Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Interventions
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Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Sympara Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ian Meredith, AM, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash Health
Locations
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Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Countries
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Other Identifiers
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STS1402
Identifier Type: -
Identifier Source: org_study_id
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