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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) (HTN-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888433
First Posted: April 27, 2009
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Vascular
April 24, 2009
April 27, 2009
September 13, 2013
February 24, 2014
May 20, 2015
June 2009
September 2010   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00888433 on ClinicalTrials.gov Archive Site
Not Provided
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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Uncontrolled Hypertension
Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
  • Experimental: Renal Denervation
    Renal Denervation and maintenance of anti-hypertensive medications
    Intervention: Device: Renal Denervation (Symplicity® Renal Denervation System)
  • No Intervention: Control
    Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
May 2015
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   France,   Germany,   Latvia,   Poland,   Spain,   Switzerland,   United Kingdom
 
 
NCT00888433
TP-058
Yes
Not Provided
Not Provided
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Murray Esler, MBBS The Baker IDI Heart & Diabetes Institute
Medtronic Vascular
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP