Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine 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 with hypertension not adequately controlled with amlodipine 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 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 5 (randomization)
Exclusion
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.3 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 :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
847 Patients enrolled
Trial Details
Trial ID
NCT00778921
Start Date
October 1 2008
End Date
June 1 2009
Last Update
October 27 2016
Active Locations (7)
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1
Investigative Site
Buenos Aires, Argentina
2
Investigative Site
Berlin, Germany
3
Investigative Site
Oslo, Norway
4
Investigative Site
Warsaw, Poland