Status:
COMPLETED
Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Lead Sponsor:
Novartis
Conditions:
Moderate to Severe Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertensio...
Eligibility Criteria
Inclusion
- Outpatients ≥ 18 years of age
- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2
Exclusion
- Mild to moderate hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
- Patients on a combination of 3 or more antihypertensive medications
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00841672
Start Date
January 1 2009
End Date
September 1 2009
Last Update
July 12 2011
Active Locations (6)
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1
Investigative Site
Berlin, Germany
2
Investigative Site
Manila, Philippines
3
Investigative Site
Bucharest, Romania
4
Investigative Site
Moscow, Russia