Title
To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia
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
Phase
Phase 4Lead Sponsor
Jichi Medical UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hypertension InsomniaIntervention/Treatment
suvorexant ...Study Participants
82The 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.
The study consists of a 4-week run-in period and a 2-week treatment period.
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Placebo once daily before bedtime.
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Inclusion Criteria: [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. Exclusion Criteria: 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
| Event Type | Organ System | Event Term |
|---|
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
nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2weeks. Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).
Percentage change in NT-proBNP from baseline to 2 weeks
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
To compare the efficacy of suvorexant versus placebo on morning SBP variability by ABPM Variability: SD Change: value at 2 weeks minus value at baseline
Percentage change in UACR from baseline to 2 weeks
nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2 weeks. Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).
