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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 February 2015 |
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Main ID: |
NCT00224549 |
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Date of registration:
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16/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PHARES Study: Management of Resistant Hypertension
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Scientific title:
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Management of Resistant Hypertension -Pharmacokinetic Assessment of Different Antihypertensive Regimen -Comparison of Two Treatment Strategies: Increase Sodium Depletion or Combined Blockage of Renin-angiotensin System (RAS) |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00224549 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Guillaume BOBRIE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: irbesartan, amlodipine and hydrochlorothiazide
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Primary Outcome(s)
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Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device
[Time Frame: at week 12]
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Secondary Outcome(s)
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Echocardiography (week 0 and 12)
[Time Frame: week 0 and 12]
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Other explorations:
[Time Frame: during]
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blood and urinary electrolytes with creatinemia at week 0, 4, 8, 10 and 12
[Time Frame: at week 0, 4, 8, 10 and 12]
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brain natriuretic peptide (BNP), active renin, aldosterone at week 0 and 12
[Time Frame: at week 0 and 12]
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During the study BP will be evaluated every 4 weeks by home blood pressure measurement [HBPM] in order to detect hypotension)
[Time Frame: every 4 weeks]
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Efficacy: mean day-time diastolic blood pressure (DBP) at week 12, mean 24 hours SBP and DBP at week 12 measured with an ABPM device
[Time Frame: at week 12,]
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Biological examinations:
[Time Frame: during the study]
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Safety and tolerability:
[Time Frame: during the study]
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Pharmacokinetics of drugs (week 0 and 12)
[Time Frame: week 0 and 12]
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Endothelial function (week 0 and 12)
[Time Frame: week 0 and 12]
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Treatment compliance (study drug accounting, N-acetyl-seryl-aspartyl-lysyl-proline [Ac SDKP] for angiotensin converting enzyme inhibitor [ACEi])
[Time Frame: during the study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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