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
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.
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 WeeksChange 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 32Overall 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
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
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