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

Phase 1 Completed 47 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindDiagnostic

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.

Timeline

Start: 2008-07
Primary completion: 2009-02
Completion: 2009-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Amlodipine 10 Milligrams vs Placebo; p = 0.001; Least Squares Mean -11.7 (90% CI -18.1 to -5.4); ANCOVA NCT00789321 ↗

paper bioimpedance (-11.7 Ω [-18.1 to -5.4], -18.3 Ω [-26.2 to -10.4], and -20.9 Ω [-29.7 to -12.0]; all, P≤0.001) PMID 22385927 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	10 mg	—