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

August 10, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
amlodipine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-106
  • 2008_580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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