Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

Novartis1,254 enrolled

Overview

This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy. The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning. The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

1,254

Conditions

Hypertension

Interventions

AmlodipineDRUG

Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.

hydrochlorothiazideDRUG

Hydrochlorothiazide 12.5 mg capsules were taken orally once daily

AliskirenDRUG

Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female outpatients ≥ 18 years of age * Participants with essential hypertension: * Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and \< 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.) * All participants must have a msSBP ≥ 150 mmHg and \< 180 mmHg at Visit 2 * Written informed consent to participate in this study prior to any study procedures Exclusion Criteria: * Severe hypertension * Pregnant or nursing (lactating) women * Pre-menopausal women not taking accepted form of birth control * Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1 * History of cardiovascular conditions * Uncontrolled Type 1 or Type 2 diabetes mellitus * Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures Other protocol-defined inclusion/exclusion criteria may apply.

Locations (10)

Investigative Site

Toronto, Canada

Investigative Site

San José, Costa Rica

Investigative Site

Paris, France

Investigative Site

Bonn, Germany

Outcomes

Primary Outcomes

Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks

Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.

Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24

Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.

Time frame: Baseline to 24 weeks

Secondary Outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32

Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.

Time frame: Baseline to 32 weeks

Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks

Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.

Data from ClinicalTrials.gov

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