Status:
COMPLETED
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hyp...
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 classica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
1254 Patients enrolled
Trial Details
Trial ID
NCT00797862
Start Date
November 1 2008
End Date
November 1 2010
Last Update
October 17 2011
Active Locations (10)
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1
Investigative Site
Toronto, Canada
2
Investigative Site
San José, Costa Rica
3
Investigative Site
Paris, France
4
Investigative Site
Bonn, Germany