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

Phase 3

Completed

Interventions: Drug: Aliskiren/amlodipine 300/10 mg tablet
Drug: Amlodipine 10 mg capsule

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Aliskiren/amlodipine 300/10 mg tablet	Aliskiren/amlodipine 300/10 mg tablet	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.
Amlodipine 10 mg capsule	Amlodipine 10 mg capsule	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.

Primary Outcome Measures

Name	Time	Method
Mean Sitting Systolic Blood Pressure (msSBP)	Baseline to end of study (Week 8)	Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)

Secondary Outcome Measures

Name	Time	Method
Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline to end of study (Week 8)	Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)
Systolic Blood Pressure Response	Baseline to end of study (Week 8)	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)
Diastolic Blood Pressure Response	Baseline to end of study (Week 8)	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)
Blood Pressure Control	End of study (Week 8)	Percentage of patients achieving blood pressure control (msSBP \< 140 mm Hg and msDBP \< 90 mm Hg) at end of study