None listed
Conditions
Interventions
Group 1 Type of group
Patients with controlled BP (group 1.1): irbesartan / HCTZ 150 / 12.5 mg 1 tablet once daily in the morning for 10 weeks
Patients with uncontrolled BP (group 1.2): irbesartan / HCTZ 300/25 mg I tablet once daily in the morning for 10 weeks
Group name:Group 2 Type of group
Group 2.2 patients: irbesartan / HCTZ 300/25 mg 1 tablet once daily in the morning for 10 weeks
Group 2.1 patients:
with controlled BP (group 2.1.1):
irbesartan / HCTZ 150 / 12.5 mg 1 tablet once daily in the morning for 10 weeks
with uncontrolled BP (group 2.1.2):
irbesartan / HCTZ 300/25 mg 1 tablet once daily in the morning for 10 weeks
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Change in mean systolic blood pressure between VI (week 0) and V4 (week 10), measured in the doctors office with the automatic device Timepoints:between VI (week 0) and V4 (week 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Using the following criteria: • Change in average DBP • Percentage of controlled patients in the two groups in V4 (week 10) using the following criteria: SBP 30 kg / m2) against non-obese patients (BMI <30 kg / m2) Timepoints:between V1 (week 0) and V4 (Week 10) ; Outcome name:Using the following criteria: • Change in average SBP and DBP • Percentage of controlled patients in the two groups in Week 10 using the following criteria: SBP <140 mm Hg and DBP <90 mm Hg in non-diabetics and SBP <130 mm Hg and DBP <80 mm Hg in diabetics. Measure:Comparison of the antihypertensive efficacy of the Irbesartan / HCTZ combination between VI (week 0) and V4 (Week 10) in diabetic patients versus non-diabetic patients Timepoints:between VI (week 0) and V4 (Week 10) | — |
Countries
Arabia Saudi, Argentina, Argeria, Brazil, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Lebano, Mexico, Morocco, Panama, Peru, Tunisia, United Arab Emirates, Venezuela
Outcome results
None listed