Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00500604
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1617
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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.
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Irbesartan/hydrochlorothiazide * 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. B Valsartan/hydrochlorothiazide * 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. A Hydrochlorothiazide * 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. B Hydrochlorothiazide * 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.
- Primary Outcome Measures
Name Time Method Reduction in mean SBP as measured by HBPM From week 0 to week 24
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇻🇳Ho Chi Minh City, Vietnam