Status:
COMPLETED
PHARES Study: Management of Resistant Hypertension
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The stu...
Detailed Description
Tested hypothesis: For essential resistant hypertension, a new regimen based on intensive RAS blockage is non inferior to the recommended regimen based on intensive sodium depletion. Primary objectiv...
Eligibility Criteria
Inclusion
- Primary hypertension
- Resistant hypertension defined by mean day-time SBP \> 135 mmHg and DBP \> 85 mmHg (determined with ABPM device) after a standardized 4-week regimen including irbesartan, amlodipine and HCTZ.
Exclusion
- Secondary hypertension
- Unstable angina, history of stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months
- History of cough with ACEi or gynecomastia with antialdosterones
- Heart failure (New York Heart Association \[NYHA\] III-IV)
- Contraindication to beta blockers because of bronchopathy or auriculoventricular block
- Diabetes mellitus (type 1 or 2) with HbA1C \> 8%
- Renal failure with creatinine clearance \< 40ml/min (COCKROFT evaluation)
- Arm circumference \> 42 cm
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00224549
Start Date
April 1 2005
End Date
August 1 2009
Last Update
February 28 2011
Active Locations (1)
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1
Investigation Clinical Center European Georges Pompidou Hospital
Paris, Île-de-France Region, France, 75015