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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: Comparator: Placebo

Drug: Comparator: amlodipine besylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00789321

0000-106

2008_580

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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