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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Comparator: amlodipine besylate

Comparator: Placebo

About this trial

This is an interventional diagnostic trial for Hypertension

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

amlodipine

Placebo to amlodipine

Outcomes

Primary Outcome Measures

Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2

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

Least Squares Mean Difference from Baseline

Full Information

NCT ID

NCT00789321

First Posted

November 10, 2008

Last Updated

August 10, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00789321

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

amlodipine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo to amlodipine

Intervention Type

Drug

Intervention Name(s)

Comparator: amlodipine besylate

Intervention Description

Two 5 mg tablets amlodipine daily for 6 weeks.

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo

Intervention Description

Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Primary Outcome Measure Information:

Title

Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2

Description

Time Frame

Baseline and 2 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2

Description

Least Squares Mean Difference from Baseline

Time Frame

Baseline and 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

22385927

Citation

Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.

Results Reference

derived

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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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