NCT00703703已完成1 期
A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7
研究概览
简要总结
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females ≥ 50 years
- •Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2
排除标准
- •Known or suspected allergy to tolterodine ER or darifenacin or their components
- •Subjects with irregular day and night patterns such as night shift workers
- •Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)
- •Medication with potential known to affect heart rate
- •History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- •Pregnant or nursing women
- •Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Darifenacin
干预措施: Darifenacin (Drug)
2
Active Comparator
Tolterodine
干预措施: Tolterodine (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7
时间窗: 7 days
次要结局
- Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7(7 days)
研究者
研究点 (1)
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