The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Aliskiren/amlodipine 150/5 mg/day
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipine 150/10 mg/day
Novartis Investigative Site
Beek en Donk, Netherlands
Novartis Investigative Site
Bosch, Netherlands
Novartis Investigative Site
Hoogwoud, Netherlands
Novartis Investigative Site
Lichtenvoorde, Netherlands
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
Time frame: Baseline, 4 weeks
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Placebo to Amlodipine 5 mg/day
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