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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

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
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: March 2009

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

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• 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

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):

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00789321
• Other Study ID Numbers: 0000-106; 2008_580
• First Posted: November 11, 2008
• 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; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents