ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan

Criteria

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.