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Completed

NCT Number: NCT00789321

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

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

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: amlodipine besylate

Drug

Two 5 mg tablets amlodipine daily for 6 weeks.

Comparator: placebo

Drug

Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2008
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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