An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Novartis556 enrolled

Overview

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

556

Conditions

Hypertension

Interventions

AliskirenDRUG

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

AmlodipineDRUG

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

HydrochlorothiazideDRUG

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients 18 years of age or older * Male or female patients are eligible * For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4 * For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4) Exclusion Criteria: * Severe hypertension * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion/exclusion criteria may apply

Locations (8)

Investigative Site

Santa Fe, New Mexico, United States

Investigator Site

Investigative Site, Belgium

Investigative Center

Investigative Center, Denmark

Investigative Site

Investigative Site, Finland

Outcomes

Primary Outcomes

Overall Percentage of Patients With Adverse Events

Time frame: 52 weeks

Secondary Outcomes

Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points

Time frame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54

Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg

Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54

Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)

Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54

Data from ClinicalTrials.gov

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