Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

Detailed Description
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Primary objective: Sitting systolic blood pressure (average of three readings) will be the primary outcome variable. Secondary To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic; To compare the duration of follow-up, during which a steady blood pressure control will be achieved; To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups; To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Official Title
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Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day
* Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men within an age range from 30 to 69 years with uncomplicated hypertension. Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology. Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position). Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs. The patient must provide informed written consent. Exclusion Criteria: Premenopausal women not applying anticonception. A history of cardiovascular disease. Secondary hypertension. Electrocardiographic left ventricular hypertrophy. More than two cardiovascular risk factors in addition to hypertension. Diabetes mellitus. Renal dysfunction. Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks. Severe non-cardiovascular disease. Known contra indications for the first-line study medications.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 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: amlodipine plus valsartan<br>In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. | Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day<br>* Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning<br>* Other names: ExForge®;|
| Active Comparator: hydrochlorothiazide plus bisoprolol<br>In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol | Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day<br>* hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning<br>* Other names: Lodoz®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting Systolic Blood Pressure on Automated Measurement | Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome. | 6 months follow-up after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Blood Pressure Control | The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic. | 6 months follow-up after randomization | 
| Side-effects to Study Medications |  | 6 months follow-up after randomization | 
| Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up | This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic) | 6 months follow-up after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Hypertension, Blacks, Africa, Blood pressure control, Side-effects