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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00888433
First received: April 24, 2009
Last updated: October 31, 2014
Last verified: October 2014
Results First Received: September 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Uncontrolled Hypertension
Intervention: Device: Renal Denervation (Symplicity® Renal Denervation System)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
84 subjects excluded pre-randomization due to blood pressure value at baseline visit (n=36); ineligible anatomy (n=30); declined participation (n=10); and other exclusion criteria (n=8).

Reporting Groups
  Description
Renal Denervation Renal Denervation and maintenance of anti-hypertensive medications
Control Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

Participant Flow:   Overall Study
    Renal Denervation     Control  
STARTED     52     54  
COMPLETED     49     51  
NOT COMPLETED     3     3  
Withdrawal by Subject                 1                 2  
Missed Visit                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Renal Denervation Renal Denervation and maintenance of anti-hypertensive medications
Control Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
Total Total of all reporting groups

Baseline Measures
    Renal Denervation     Control     Total  
Number of Participants  
[units: participants]
  52     54     106  
Age  
[units: years]
Mean ± Standard Deviation
  58.2  ± 11.9     58.3  ± 12.3     58.2  ± 12.0  
Gender  
[units: participants]
     
Female     18     27     45  
Male     34     27     61  
Region of Enrollment  
[units: participants]
     
France     1     3     4  
Poland     1     1     2  
Belgium     4     2     6  
Spain     2     2     4  
Australia     5     5     10  
Austria     1     2     3  
Latvia     3     4     7  
Germany     32     29     61  
Switzerland     0     1     1  
United Kingdom     3     5     8  



  Outcome Measures

1.  Primary:   Office Systolic Blood Pressure Reduction   [ Time Frame: Baseline to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Murray Esler, Principal Investigator
Organization: Baker IDI Heart and Diabetes Institute
e-mail: murray.esler@bakeridi.edu.au


Publications of Results:
Publications automatically indexed to this study:


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00888433     History of Changes
Other Study ID Numbers: TP-058
Study First Received: April 24, 2009
Results First Received: September 13, 2013
Last Updated: October 31, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration