NCT00789321已完成1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
研究概览
简要总结
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
时间窗: 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.
次要结局
- Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2(Baseline and 2 weeks)
研究者
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