NCT01612078终止3 期
A Double-blind, Randomized and Placebo-controlled Study to Evaluate the Efficacy and Safety of L-threo-3,4-dihydroxyphenylserine (Droxidopa) on Orthostatic Hypotension Treatment in Hemodialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in mean ΔSBP after hemodialysis
研究概览
简要总结
Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. Since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged great than 20 years of age
- •Patient with at least 3 month documented requirement of regular hemodialysis session
- •Patient with a decrease of 20 mmHg in SBP or 10 mmHg in DBP within 5 minutes of standing after the end of hemodialysis in at least 2 of 3 sessions during the screening period.
- •Subject with subjective complain of light headedness related to the orthostatic hypotension AND with a VAS score 4 in at least 2 of 3 sessions during the screening period.
- •Willing and able to comply with the study procedure and sign a written informed consent
排除标准
- •Female who is pregnant, lactating or planning to be pregnant within 3 months, or female of childbearing potential who is not using medically recognized method of contraception
- •Subject with closed angle glaucoma
- •Subject with severe hypertension
- •Subject with liver disorder
- •Subject with Hct great than 36%
- •Subject with confusion, hallucination, or delusion
- •Subject with severe disease which may limit survival during the study period, or confound the results of the study as judged by the investigator, such as hyperthyroidism, artery stenosis, severe lung disorders, severe asthma, chronic open angle glaucoma, uncontrolled diabetic gangrene
- •Subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium
- •Subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization
- •Subject who use of any investigational product within 4 weeks prior to randomization
- •Subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator
- •Histories of hypersensitive to droxidopa
- •Histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator
- •Histories of hemorrhage complication within 3 months before the screening visit, such as GI bleeding, intracranial bleeding or traumatic hemorrhage, and are not suitable to participate the trial as judged by the investigator
- •In investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures
研究组 & 干预措施
Droxidopa, antihypotensive drug, tablet
Experimental
干预措施: Droxidopa (Drug)
placebo, tablet
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in mean ΔSBP after hemodialysis
时间窗: from Week 0 (visit 1-3) to Week 4 (visit 13-15)
ΔSBP = supine SBP (right before standing up) - nadir standing SBP
次要结局
- Adverse event,Serious adverse event(from week 0 to week 5)
研究者
研究点 (1)
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