Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Novartis256 enrolled

Overview

This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

256

Conditions

Essential Hypertension ( Mild to Moderate)

Interventions

AliskirenDRUG

Aliskiren 150 or 300 mg

HydrochlorothiazideDRUG

Hydrochlorothiazide 12.5 or 25 mg

AmlodipineDRUG

Amlodipine 5 or 10 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients ≥ 18 years of age * Patients with a diagnosis of mild to moderate hypertension at Visit 1 * All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3 Exclusion Criteria: * Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg * Secondary form of hypertension * Current diagnosis of heart failure (NYHA Class II-IV) * Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates) * Second or third degree heart block without a pacemaker * Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply.

Locations (4)

Investigative Site

Paris, France

Investigative Site

Budapest, Hungary

Investigative Site

Bucharest, Romania

Investigative Site

Bratislava, Slovakia

Outcomes

Primary Outcomes

Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure \[msSBP\] \< 140 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure \[msSBP\] \< 130 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 80 mmHg.

Time frame: 24 weeks

Secondary Outcomes

Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.

Time frame: 24 weeks

Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]

Time frame: Baseline and Week 24

Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]

Response for mean sitting Systolic Blood Pressure \[msSBP\] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure \[msSBP\] \< 140 mmHg (non diabetics) or \< 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure \[msDBP\] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure \[msDBP\] \< 90 mmHg (non diabetic) or \< 80 mmHg (diabetics).

Time frame: 24 weeks

Data from ClinicalTrials.gov

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