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

Phase 1

Completed

• Conditions: Hypertension

• Registration Number: NCT00789321
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Results First Submitted: 2010-04-30
• Results First Submitted QC: 2010-06-08
• Results First Posted: 2010-07-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2	Baseline and 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2	Baseline and 2 weeks	Least Squares Mean Difference from Baseline