Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
Eligibility Criteria
Inclusion
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
- Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
- All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 4
Exclusion
- Severe 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT00777946
Start Date
October 1 2008
End Date
May 1 2009
Last Update
July 12 2011
Active Locations (9)
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1
Investigative site
Estonia, Estonia
2
Investigative site
France, France
3
Investigative Site
Iceland, Iceland
4
Investigative Site
India, India