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

NCT00789321 | Completed Phase 1 Results

• 2 other identifiers: 0000-1062008_580
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 weeks

Secondary Outcomes (1)

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

  Baseline and 2 weeks

Study Arms (2)

1

EXPERIMENTAL

amlodipine

Drug: Comparator: amlodipine besylate

2

PLACEBO COMPARATOR

Placebo to amlodipine

Drug: Comparator: Placebo

Interventions

Comparator: amlodipine besylate DRUG

Two 5 mg tablets amlodipine daily for 6 weeks.

1

Comparator: Placebo DRUG

Two 5 mg tablets placebo to amlodipine daily for 6 weeks

2

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22385927 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

clinicaltrialsdisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 11, 2015
• Results First Posted: July 8, 2010

Record last verified: 2015-08