An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
NCT ID: NCT00402103
Last Updated: 2011-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
556 participants
INTERVENTIONAL
2006-11-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aliskiren/Amlodipine
Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Aliskiren/Amlodipine/HCTZ
Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Hydrochlorothiazide
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
Interventions
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Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Hydrochlorothiazide
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis
Locations
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Investigative Site
Santa Fe, New Mexico, United States
Investigator Site
Investigative Site, , Belgium
Investigative Center
Investigative Center, , Denmark
Investigative Site
Investigative Site, , Finland
Investigative Center
Investigative Center, , Germany
Investigative Site
Investigative Site, , Iceland
Investigative Site
Investigative Site, , India
Investigative Site
Investigative Site, , Switzerland
Countries
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References
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Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.
Other Identifiers
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CSPA100A2301
Identifier Type: -
Identifier Source: org_study_id
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