Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

Study Overview
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Brief Summary
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This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Official Title
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An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients

Conditions
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Moderate to Severe Hypertension

Intervention / Treatment
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* Drug: Aliskiren/amlodipine 300/10 mg tablet
* Drug: Amlodipine 10 mg capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients ≥ 18 years of age Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2 Exclusion Criteria: Mild to moderate hypertension Pregnant or nursing (lactating) women Women of child-bearing potential Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV. Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1. Uncontrolled Type 1 or Type 2 diabetes mellitus Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention Patients on a combination of 3 or more antihypertensive medications Other protocol-defined inclusion/exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren/amlodipine 300/10 mg tablet<br>Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. | Drug: Aliskiren/amlodipine 300/10 mg tablet<br>* Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.<br>|
| Active Comparator: Amlodipine 10 mg capsule<br>Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. | Drug: Amlodipine 10 mg capsule<br>* Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Systolic Blood Pressure (msSBP) | Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Diastolic Blood Pressure (msDBP) | Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | 
| Systolic Blood Pressure Response | Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | 
| Diastolic Blood Pressure Response | Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | 
| Blood Pressure Control | Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study | End of study (Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, systolic blood pressure, cardiovascular disease, aliskiren, amlodipine