Phase 1
N=47
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00789321 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2 — -7.9; 3.8 Ohms — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Comparator: amlodipine besylate (Drug); Comparator: Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2 |
-7.9; 3.8 | 0.001 sig |
| SECONDARY Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2 |
44.8; 5.8 | 0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00789321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.