Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

The secondary objectives are:

• To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24

• To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24

• To compare the difference in mean SBP evaluated by HBPM at week 16

• To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24

• To determine the incidence and severity of adverse events

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

Details

• Lead Sponsor: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan; Valsartan

Criteria

Inclusion Criteria:

• Established essential hypertension, untreated or treated but uncontrolled with treatment:

• Office SBP ≥ 160 mmHg for untreated patients

• Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.

• Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:

• ACE inhibitor / calcium channel blocker

• Beta blocker / calcium channel blocker

• Beta blocker / low dose diuretic

• ACE inhibitor / low dose diuretic

Exclusion Criteria:

• SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1

• Known or suspected causes of secondary hypertension

• Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney

• Type 1 diabetes mellitus

• Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject

• 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 any of the study drugs

• Concomitant use of any other antihypertensive treatment

• Use of any of the investigational products for this study within the 3 months prior to the study

• Inability to obtain a valid HBPM recording i.e., obesity, arm circumference > 32 cm or arrhythmia

• Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study

• Pregnant or breast-feeding women

• Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.