Insomnia with hypertensive symptoms
Conditions
Interventions
During the treatment period (2 weeks), the patients will orally receive suvorexant (20mg for 64 years or younger
15mg for 65 years or older) once daily before bedtime.
During the treatment period (2 weeks), the patients will orally receive placebo once daily before bedtime.
Sponsors
Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [At interim registration] Patients who meet the following criteria are eligible for the study: 1)Patients who give written consent of agreement to voluntarily participation in the clinical study 2)Age 20 years or older 3) Sex: Male or female 4) Treatment classification: Outpatient 5)Hypertensive patient who meet at least one of the following: a. Under antihypertensive medications b. Clinic systolic blood pressure (SBP) less than 160 mmHg 6) Patients with insomnia who meet at least one of the following: a. 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: 1) Stable unchanged antihypertensive medication for run-in period. 2) Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.
Exclusion criteria
Exclusion criteria: 1)Patients with serious liver disease. 2) Patients with serious respiratory disease. 3)Patients with secondary hypertension 4)Patients with sleep apnea syndrome 5)Patients with history of narcolepsy or cataplexy 6)Patients with history of organic cerebral disorders 7)Patients with history of hypersensitivity to suvorexant 8)Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period 9)Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period 10)Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis 11)Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant 12)Patients who are considered not to be eligible for this study by their investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: To compare the efficacy of suvorexant versus placebo on the reduction of sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. To compare the percent change from non-dippers to dippers. 2. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP by ABPM and HBPM. 3. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP variability by ABPM and HBPM. 4. Changes in the total sleep time (TST) (self-reported). 5. Changes in the time to sleep onset (TSO) (self-reported). 6. To study the correlation of changes of sleep BP parameters with changes of sleep quality parameters 7. To study the correlation of changes of urinary albumin-to-creatinine ratio (UACR) / NT-proBNP. | — |
Countries
Japan
Contacts
Public ContactSecretariat
Satt Co., Ltd. Clinical research steering group
Outcome results
None listed