Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-24 @ 3:25 AM
Study NCT ID:
NCT02250495
Status:
TERMINATED
Last Update Posted:
2015-09-14
First Post:
2014-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sympara VIBE Study for Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Company closed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2014-09-20', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with serious, device-related adverse events as a measure of safety and tolerability', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy', 'timeFrame': '30 days', 'description': 'Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician\n* Minimum six- (6) month history of diagnosis and treatment of hypertension\n\nExclusion Criteria:\n\n* Previous renal denervation or carotid barostimulation implant\n* Secondary causes of hypertension or primary pulmonary hypertension\n* Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery\n* Known or suspected baroreflex failure or significant orthostatic hypotension\n* One or more hospital admissions for a hypertensive crisis within the past year\n* 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\n* Diabetes mellitus (Type 1)\n* Chronic renal disease requiring dialysis\n* Kidney or liver transplant'}, 'identificationModule': {'nctId': 'NCT02250495', 'acronym': 'VIBE', 'briefTitle': 'The Sympara VIBE Study for Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sympara Medical, Inc.'}, 'officialTitle': 'VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension', 'orgStudyIdInfo': {'id': 'STS1402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sympara Therapeutic System', 'description': 'All subjects will wear for the Sympara device for 30 days', 'interventionNames': ['Device: Sympara Therapeutic System']}], 'interventions': [{'name': 'Sympara Therapeutic System', 'type': 'DEVICE', 'description': 'Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension', 'armGroupLabels': ['Sympara Therapeutic System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Barwon Health', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}], 'overallOfficials': [{'name': 'Ian Meredith, AM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sympara Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}