Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
NCT ID: NCT01080768
Last Updated: 2011-12-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2010-02-28
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aliskiren/amlodipine + Placebo to amlodipine
During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Aliskiren/amlodipine
Aliskiren/amlodipine 150/5 mg/day
Placebo to Amlodipine
Placebo to Amlodipine 5 mg/day
Amlodipine + Placebo to aliskiren/amlodipine
During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Amlodipine
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipine
Placebo to Aliskiren/amlodipine 150/10 mg/day
Interventions
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Aliskiren/amlodipine
Aliskiren/amlodipine 150/5 mg/day
Amlodipine
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipine
Placebo to Aliskiren/amlodipine 150/10 mg/day
Placebo to Amlodipine
Placebo to Amlodipine 5 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients not treated with amlodipine or no amlodipine in previous 1 year.
* Post-menopausal females
Exclusion Criteria
* Severe hypertension.
* Pregnant or nursing females.
* Patients with Type 1 or Type 2 diabetes mellitus
* History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay \[ELISA\] and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Beek en Donk, , Netherlands
Novartis Investigative Site
Bosch, , Netherlands
Novartis Investigative Site
Hoogwoud, , Netherlands
Novartis Investigative Site
Lichtenvoorde, , Netherlands
Novartis Investigative Site
Lieshout, , Netherlands
Novartis Investigative Site
Poortvliet, , Netherlands
Novartis Investigative Site
The Hague, , Netherlands
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Wildervank, , Netherlands
Countries
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Other Identifiers
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2009-014359-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSPA100A2201
Identifier Type: -
Identifier Source: org_study_id