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

Novartis

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension ( Mild to Moderate)

Treatments: Drug: Aliskiren; Drug: Hydrochlorothiazide; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765947

CSPP100A2360

Details and patient eligibility

About

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).

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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256 participants in 1 patient group

Aliskiren-based regimen

Experimental group

Description:

All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.

Treatment:

Drug: Aliskiren

Drug: Hydrochlorothiazide

Drug: Amlodipine