A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)

Study Overview
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Brief Summary
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This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Comparator: amlodipine besylate
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient does not have hypertension or has Stage I or II hypertension and is taking < 3 anti-hypertension medications Patient is willing to discontinue all anti-hypertensive medications during study Patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent) Patient will avoid strenuous physical activity during study Patient is a nonsmoker or has not smoked for the last 3 months Exclusion Criteria: Patient has metal implants in the leg or artificial limbs Patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease Patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening Patient has a history of stroke or seizures Patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>amlodipine | Drug: Comparator: amlodipine besylate<br>* Two 5 mg tablets amlodipine daily for 6 weeks.<br>|
| Placebo Comparator: 2<br>Placebo to amlodipine | Drug: Comparator: Placebo<br>* Two 5 mg tablets placebo to amlodipine daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2 | 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. | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2 | Least Squares Mean Difference from Baseline | Baseline and 2 weeks |