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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Calcium Channel Blockers; Hydrochlorothiazide

Criteria

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.