NCT02849184已完成4 期
A Multi-center, Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Suvorexant Versus Placebo on Sleep Pressure and Circadian Rhythm in Hypertensives With Insomnia: The Super 1 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Change in Sleep Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.
详细描述
The study consists of a 4-week run-in period and a 2-week treatment period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[At interim registration]
- •Patients who meet the following criteria are eligible for the study:
- •Patients who give written consent of agreement to voluntarily participation in the clinical study
- •Age 20 years or older
- •Sex: Male or female
- •Treatment classification: Outpatient
- •Hypertensive patient who meet at least one of the following:
- •Under antihypertensive medications
- •Clinic systolic blood pressure (SBP) less than 160 mmHg
- •Patients with insomnia who meet at least one of the following:
- •Patients with any one of the following symptoms twice a week or more and at least 1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or more longer than usual), difficulty maintaining sleep (awakening twice or more in the night), early morning awakening (awakening 2 hours or more earlier in the morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the time of awakening in the morning).
- •b. Patients with interference with social or occupational function due to the above insomnia symptoms
- •[At official registration]
- •Patients who meet the following criteria at the end of run-in period are eligible for the study:
- •Stable unchanged antihypertensive medication for run-in period.
- •Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.
排除标准
- •Patients with serious liver disease.
- •Patients with serious respiratory disease.
- •Patients with secondary hypertension
- •Patients with sleep apnea syndrome
- •Patients with history of narcolepsy or cataplexy
- •Patients with history of organic cerebral disorders
- •Patients with history of hypersensitivity to suvorexant
- •Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period
- •Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period
- •Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis
- •Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
- •Patients who are considered not to be eligible for this study by their investigator or sub-investigator
研究组 & 干预措施
suvorexant
Experimental
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks
干预措施: suvorexant (Drug)
placebo
Placebo Comparator
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Sleep Systolic Blood Pressure
时间窗: 2 weeks
To compare the efficacy of suvorexant versus placebo on sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM). Change: sleep SBP value at 2 weeks minus value at baseline
次要结局
- Changes in the Total Sleep Time(2 weeks)
- Change in Urinary Albumin-to-creatinine Ratio (UACR)(2 weeks)
- Change in Morning Systolic Blood Pressure Variability(2 weeks)
- Changes in the Time to Sleep Onset(2 weeks)
- Change in NT-proBNP(2 weeks)
- Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction(2 weeks)
- Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction(2 weeks)
研究者
Kazuomi Kario
Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine
Jichi Medical University
研究点 (3)
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