Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination ACTUA
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-115-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Outpatients of male or female age> 18 years
• Established essential hypertension treated for at least 4 weeks with an antihypertensive only {The fixed dose combination does not represent monotherapy)
• With uncontrolled Blood Pressure (BP) defined as follows: SBP> 160 mm Hg and / or DBP> 100 mm Hg in non-diabetic patients, SBP> 150 mm Hg and / or DBP> 90 mm Hg in diabetic patients
• Obtaining Informed Consent in writing signed before enrollment in the study
• SBP> 180 mm Hg and / or DBP> 110 mm Hg in VI
• Known or suspected causes of secondary hypertension
• Patient with bilateral renal artery stenosis, renal artery stenosis in solitary kidney; history of kidney transplant or having only one functional kidney
• Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (eg, beta-blocker for angina, ACE inhibitors for heart failure, etc ...)
• Known hypersensitivity to diuretics or sulfonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
• Known contraindications to the study drugs: Severe renal dysfunction (creatinine clearance <30 ml / min), Known hypokalemia (<3 mmol / L), known hypercalcemia, Severe hepatic impairment, biliary cirrhosis, cholestasis
• Impossibility of obtaining valid automatic BP registration
• Administration of any other drug under investigation within 30 days before enrollment and during the course of the study
• Presence of any severe medical or psychological condition that, in the opinion of the researcher, indicates that participation in the study is not part of the best interests of the subject
• Presence of any other condition (eg, geographic, social, etc.) that restricts or limits the participation of the subject throughout the study
• Pregnant or breastfeeding women
• Women with reproductive potential not protected by an effective birth control method of birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The average blood pressure will be calculated based on the number of measurements available as long as at least one measurement is available.<br>Measure:Change in mean systolic blood pressure between VI (week 0) and V4 (week 10), measured in the doctors office with the automatic device<br>Timepoints:between VI (week 0) and V4 (week 10)<br>
- Secondary Outcome Measures
Name Time Method