Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Study Overview
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Brief Summary
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Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

Official Title
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Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan/amlodipine 80/5 mg tablets
* Drug: Amlodipine 5 mg capsules
* Drug: Amlodipine 10 mg capsules
* Drug: Atenolol 50 mg tablets
* Drug: Atenolol 100 mg tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 18 years of age or older Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects Written informed consent to participate in the study prior to any study procedures Exclusion Criteria: Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) Evidence of a secondary form of hypertension Type 1 diabetes mellitus History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Ages Eligible for Study
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Minimum Age: 18 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: Valsartan/amlodipine 160/10 mg<br>Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. | Drug: Valsartan/amlodipine 80/5 mg tablets<br> <br> |
| Active Comparator: Atenolol/amlodipine 100/10 mg<br>Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. | Drug: Amlodipine 5 mg capsules<br> <br> Drug: Amlodipine 10 mg capsules<br> <br> Drug: Atenolol 50 mg tablets<br> <br> Drug: Atenolol 100 mg tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) |  | Baseline and Week 8 | 
| Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) |  | Baseline and Week 24 | 
| Change From Baseline of Augmentation Index (Aix) at Week 8 | To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated. | Baseline and Week 8 | 
| Change From Baseline of Aix at Week 24 |  | Baseline and Week 24 | 
| Change From Baseline of Aix Corrected to Heart Rate at Week 24 | The heart rate correction was computed by a multivariate model analysis | Baseline and Week 24 | 
| Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement) |  | Baseline and Week 24 | 
| Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) | Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure. | Baseline and Week 24 | 
| Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center) |  | Baseline and Week 24 | 
| Change From Baseline of SBP/DBP at Week 24 (Office BP) |  | Baseline and Week 24 | 
| Change From Baseline of Pulse Pressure at Week 24 (Office BP) |  | Baseline and Week 24 |