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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00888433 |
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Date of registration:
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24/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
HTN-2 |
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Scientific title:
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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00888433 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Australia
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Austria
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Belgium
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France
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Germany
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Latvia
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Poland
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Murray Esler, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Baker IDI Heart & Diabetes Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
- on 3 or more antihypertensive medications
- >= 18 and =< 85 years of age.
Exclusion Criteria:
- renal artery abnormalities
- eGFR < 45mL/min
- MI, angina, CVA within 6 months
- Type 1 diabetes
- ICD or pacemaker, or any other metallic implant not compatible with MRI
- others
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Uncontrolled Hypertension
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Intervention(s)
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Device: Renal Denervation (Symplicity® Renal Denervation System)
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Primary Outcome(s)
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Office Systolic Blood Pressure Reduction
[Time Frame: Baseline to 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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