NCT00413790已完成4 期
A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the 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
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 162
- 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
- 否
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.)
- •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
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
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy SubjectsHealthyNCT00703703Novartis117
已完成
1 期
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease PatientsCoronary Artery DiseaseNCT03255512Bayer41
已完成
3 期
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by SurgeryRecurrent MelanomaStage IIIA Skin MelanomaStage IIIB Skin MelanomaStage IIIC Skin MelanomaStage IV Skin MelanomaMucosal MelanomaNCT00110019National Cancer Institute (NCI)823
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With NarcolepsyHealthy ParticipantsNarcolepsyNCT03748979Takeda57
已完成
3 期
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)Hereditary AngioedemaNCT05139810Ionis Pharmaceuticals, Inc.91