Comparator: amlodipine besylate
DrugTwo 5 mg tablets amlodipine daily for 6 weeks.
NCT Number: NCT00789321
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.
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Notify Me50 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two 5 mg tablets amlodipine daily for 6 weeks.
Two 5 mg tablets placebo to amlodipine daily for 6 weeks
Time frame: Baseline and 2 weeks
Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.
Time frame: Baseline and 2 weeks
Least Squares Mean Difference from Baseline
Merck Sharp & Dohme LLC
Industry
A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension
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