Hypertension
Conditions
Brief 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
Interventions
150/12.5mg tablet and 300/12.5mg tablet
80/12.5mg tablet and 160/12.5mg tablet
DRUGHydrochlorothiazide
12.5 mg administered orally, once daily in the morning
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mean SBP as measured by HBPM | From week 0 to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in mean DBP as measured by HBPM | From week 0 to weeks 16 and 24 |
| Reduction in mean morning and evening SBP as measured by HBPM | From week 0 to weeks 16 and 24 |
| Reduction in mean morning and evening DBP as measured by HBPM | From week 0 to weeks 16 and 24 |
| Adverse events, vital signs, laboratory tests | From visit 1 to end of study |
| Number of normalised patients as measured by HBPM | From week 0 to weeks 16 and 24 |
| Number of normalised patients evaluated at the doctor's office | From week 0 to weeks 16 and 24 |
| Reduction in mean SBP as measured by HBPM | From week 0 to week 16 |
| Reduction in mean SBP and mean DBP evaluated at the doctor's office | From week 0 to weeks 16 and 24 |
Countries
Egypt, Hong Kong, India, Indonesia, Malaysia, Morocco, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Tunisia, Vietnam
Outcome results
None listed