Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.