Status:
COMPLETED
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\]...
Eligibility Criteria
Inclusion
- Outpatients 18 years of age or older
- Male or female patients are eligible
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)
Exclusion
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT00402103
Start Date
November 1 2006
End Date
April 1 2008
Last Update
March 10 2011
Active Locations (8)
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1
Investigative Site
Santa Fe, New Mexico, United States
2
Investigator Site
Investigative Site, Belgium
3
Investigative Center
Investigative Center, Denmark
4
Investigative Site
Investigative Site, Finland