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

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ClinicalTrials.gov Identifier: NCT00789321
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : July 8, 2010
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Comparator: amlodipine besylate Drug: Comparator: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : July 2008
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789321


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00789321     History of Changes
Other Study ID Numbers: 0000-106
2008_580
First Posted: November 11, 2008    Key Record Dates
Results First Posted: July 8, 2010
Last Update Posted: August 11, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents