Viewing Study NCT00224549



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00224549
Status: COMPLETED
Last Update Posted: 2011-02-28
First Post: 2005-09-16

Brief Title: PHARES Study Management of Resistant Hypertension
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2007-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 study hypothesis is that these two regimens one based on increasing diuretics and the other based on increasing renin angiotensin system blockage may not differ in terms of efficacy
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 objective To demonstrate non-inferiority ie difference between the two regimen less than 5 mmHg for the mean day-time SBP at week 12

One treatment arm including irbesartan 300 mg hydrochlorothiazide HCTZ 125mg amlodipine 5 mg ramipril 10mg and bisoprolol 10 mg
One treatment arm including irbesartan 300 mg HCTZ 125mg amlodipine 5 mg spironolactone 25 mg furosemide 40 mg and amiloride 5 mg

Secondary objectives

To assess clinical and biological safety and efficacy of these regimen
To evaluate predicted factors of controlled or uncontrolled BP
To evaluate compliance to treatment
To compare the cost of the different strategies
To compare the two strategies in terms of endothelial function and left ventricular diastolic filling

Study design

Period 1 from week-4 to week 0 4-week treatment for all patients with irbesartan 300 mg HCTZ 125mg amlodipine 5 mg At the end of this period an ABPM will be performed only patients with a mean day time SBP135 andor DBP85 mmHg will be randomized for a further 3 months treatment
Period 2 from week 0 to week 4 patients will be randomized in two groups the first one receiving spironolactone 25mg and the second one receiving ramipril 5 mg as add-on therapy on top of the previous tri-therapy
Period 3 from week 4 to week 8 Patients with BP controlled at week 4 ie mean home blood pressure measurement HBPM 13585 mmHg at week 4 remain on the same treatment For those uncontrolled ie mean HBPM 13585 mmHg at week 4 furosemide 20 mg will be added in the first group and ramipril will be titrated to 10 mg in the second group
Period 4 from week 8 to week 10 Patients with BP controlled at week 8 ie mean HBPM 13585 mmHg at week 8 remain on the same treatment For those uncontrolled ie mean HBPM 13585 mmHg at week 8 furosemide will be titrated to 40 mg in the first group and bisoprolol 5 mg will be added in the second group
Period 5 from week 10 to week 12 end of the study Patients with BP controlled at week 10 ie mean HBPM 13585 mmHg at week 10 remain on the same treatment For those uncontrolled ie mean HBPM 13585 mmHg at week 10 amiloride 5 mg will be added to the previous treatment in the first group and bisoprolol will be titrated to 10 mg in the second group

Reasons for treatment discontinuation

Patient decision
Informed consent withdrawal
SBP180 mmHg or 100 mmHg HBPM whatever the time during the trial
Adverse events related to treatment or not

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None