Status:
COMPLETED
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypertension
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00789321
Start Date
July 1 2008
End Date
March 1 2009
Last Update
August 11 2015
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