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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Amlodipine (Drug); hydrochlorothiazide (Drug); Aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis


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.

Clinical Details

Official title: A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome:

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

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

Secondary outcome:

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

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

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24

Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

Investigative Site, Toronto, Canada

Investigative Site, San Jose, Costa Rica

Investigative Site, Paris, France

Investigative Site, Bonn, Germany

Investigative Site, Athens, Greece

Investigative Site, Guatemala city, Guatemala

Investigative Site, Cape Town, South Africa

Investigative Site, Basel, Switzerland

Investigative Site, London, United Kingdom

Investigative Site, Caracas, Venezuela

Additional Information

Starting date: November 2008
Last updated: October 7, 2011

Page last updated: August 23, 2015

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