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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amlodipine

Criteria

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