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

NCT ID: NCT00789321

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

1

amlodipine

Group Type: EXPERIMENTAL

Comparator: amlodipine besylate

Intervention Type: DRUG

Two 5 mg tablets amlodipine daily for 6 weeks.

2

Placebo to amlodipine

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Interventions

Comparator: amlodipine besylate

Two 5 mg tablets amlodipine daily for 6 weeks.

Intervention Type: DRUG

Comparator: Placebo

Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 22385927 (View on PubMed)

Other Identifiers

2008_580

Identifier Type: -

Identifier Source: secondary_id

0000-106

Identifier Type: -

Identifier Source: org_study_id