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

Study Overview
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Brief Summary
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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

Official Title
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A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan/hydrochlorothiazide
* Drug: Valsartan/hydrochlorothiazide
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks period 2: One 150/12.5mg tablet every morning for 8 weeks. period 3: One 300/12.5mg tablet every morning for 8 weeks. period 4: Two 150/12.5mg tablets every morning for 8 weeks. | Drug: Irbesartan/hydrochlorothiazide<br>* 150/12.5mg tablet and 300/12.5mg tablet<br>Drug: Hydrochlorothiazide<br>* 12.5 mg administered orally, once daily in the morning<br>|
| Active Comparator: B<br>period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks period 2: One 80/12.5mg tablet every morning for 8 weeks. period 3: One 160/12.5mg tablet every morning for 8 weeks. period 4: Two 80/12.5mg tablets every morning for 8 weeks. | Drug: Valsartan/hydrochlorothiazide<br>* 80/12.5mg tablet and 160/12.5mg tablet<br>Drug: Hydrochlorothiazide<br>* 12.5 mg administered orally, once daily in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean SBP as measured by HBPM |  | From week 0 to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Reduction in mean SBP and mean DBP evaluated at the doctor's office |  | From week 0 to weeks 16 and 24 | 
| 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 | 
| Adverse events, vital signs, laboratory tests |  | From visit 1 to end of study |