Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) (HTN-2)
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ClinicalTrials.gov Identifier: NCT00888433 |
Recruitment Status :
Completed
First Posted : April 27, 2009
Results First Posted : February 24, 2014
Last Update Posted : May 20, 2015
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Sponsor:
Medtronic Vascular
Information provided by (Responsible Party):
Medtronic Vascular
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Tracking Information | ||||
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First Submitted Date ICMJE | April 24, 2009 | |||
First Posted Date ICMJE | April 27, 2009 | |||
Results First Submitted Date ICMJE | September 13, 2013 | |||
Results First Posted Date ICMJE | February 24, 2014 | |||
Last Update Posted Date | May 20, 2015 | |||
Study Start Date ICMJE | June 2009 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Office Systolic Blood Pressure Reduction [ Time Frame: Baseline to 6 months ] The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) | |||
Official Title ICMJE | Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) | |||
Brief Summary | An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Uncontrolled Hypertension | |||
Intervention ICMJE | Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
106 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2015 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Belgium, France, Germany, Latvia, Poland, Spain, Switzerland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00888433 | |||
Other Study ID Numbers ICMJE | TP-058 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Medtronic Vascular | |||
Study Sponsor ICMJE | Medtronic Vascular | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medtronic Vascular | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |