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
干预措施
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
研究组 & 干预措施
1
Experimental
amlodipine
干预措施: Comparator: amlodipine besylate (Drug)
2
Placebo Comparator
Placebo to amlodipine
干预措施: Comparator: Placebo (Drug)
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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