Hypertension
Conditions
Brief summary
To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.
Interventions
DRUGIrbesartan - Hydrochlorothiazide
150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone * With uncontrolled Blood Pressure (BP) defined as: * SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients * SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients
Exclusion criteria
* SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1 * Known or suspected causes of secondary hypertension * Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney * Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc…). * Known hypersensitivity to diuretics or sulphonamides 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 \<30ml/min) * Known hypokaliemia (\< 3 mmol/L) , known hypercalcemia * Severe hepatic impairment, biliary cirrhosis, cholestasis * Inability to obtain a valid automatic BP measurement recording * Administration of any other investigational drug within 30 days prior to study entry and during the course of the study * Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the subject. * Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study. * Pregnant or breast-feeding women * Women of childbearing potential not protected by effective contraceptive method of birth control The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean Systolic Blood Pressure | between Visit 1 (Week 0) and Visit 4 (Week 10) |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean Diastolic Blood Pressure | between Visit 1 (Week 0) and Visit 4 (Week 10) |
Countries
Algeria, Argentina, Brazil, Colombia, Ecuador, Egypt, Guatemala, Lebanon, Mexico, Morocco, Panama, Peru, Saudi Arabia, Tunisia, United Arab Emirates, Venezuela
Outcome results
None listed