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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 10, 2008
Last updated: August 10, 2015
Last verified: August 2015
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.

Condition Intervention Phase
Drug: Comparator: amlodipine besylate
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2 [ Time Frame: 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:
  • Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2 [ Time Frame: Baseline and 2 weeks ]
    Least Squares Mean Difference from Baseline

Enrollment: 47
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Comparator: amlodipine besylate
Two 5 mg tablets amlodipine daily for 6 weeks.
Placebo Comparator: 2
Placebo to amlodipine
Drug: Comparator: Placebo
Two 5 mg tablets placebo to amlodipine daily for 6 weeks


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00789321

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00789321     History of Changes
Other Study ID Numbers: 0000-106
Study First Received: November 10, 2008
Results First Received: April 30, 2010
Last Updated: August 10, 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on April 21, 2017