ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Irbesartan - Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708344

IRBEH_R_02931

Details and patient eligibility

About

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.

Enrollment: 832 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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832 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Usual elective titration regimen

Treatment:

Drug: Irbesartan - Hydrochlorothiazide

Drug: Irbesartan - Hydrochlorothiazide

Group 2

Active Comparator group

Description:

Active elective titration regimen

Treatment:

Drug: Irbesartan - Hydrochlorothiazide

Drug: Irbesartan - Hydrochlorothiazide