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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00789321
First received: November 10, 2008
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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
Hypertension
Drug: Comparator: amlodipine besylate
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00789321

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

No publications provided by Merck Sharp & Dohme Corp.

Additional 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
Study First Received: November 10, 2008
Results First Received: April 30, 2010
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014