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

Novartis485 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

485

Conditions

Moderate to Severe Hypertension

Interventions

Aliskiren/amlodipine 300/10 mg tabletDRUG

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.

Amlodipine 10 mg capsuleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Investigative Site

Berlin, Germany

Investigative Site

Manila, Philippines

Investigative Site

Bucharest, Romania

Investigative Site

Moscow, Russia

Investigative Site

Outcomes

Primary Outcomes

Mean Sitting Systolic Blood Pressure (msSBP)

Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)

Time frame: Baseline to end of study (Week 8)

Secondary Outcomes

Mean Sitting Diastolic Blood Pressure (msDBP)

Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: End of study (Week 8)

Data from ClinicalTrials.gov

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