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

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

• Drug: Comparator: amlodipine besylate
  Two 5 mg tablets amlodipine daily for 6 weeks.
• Drug: Comparator: Placebo
  Two 5 mg tablets placebo to amlodipine daily for 6 weeks

• Experimental: 1
  amlodipine
  Intervention: Drug: Comparator: amlodipine besylate
• Placebo Comparator: 2
  Placebo to amlodipine
  Intervention: Drug: Comparator: Placebo

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