A Phase 4 interventional study of suvorexant and Placebo in Hypertension and Insomnia, sponsored by Jichi Medical University. Completed at 3 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Jichi Medical University · Phase 4, Interventional, and Treatment
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.
The study consists of a 4-week run-in period and a 2-week treatment period.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 82 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Jichi Medical University is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
[At interim registration]
Patients who meet the following criteria are eligible for the study:
Hypertensive patient who meet at least one of the following:
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:
Exclusion Criteria:
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks
Drug: suvorexant
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Other: Placebo
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Also known as: Belsomra
Placebo once daily before bedtime.
Change in Sleep Systolic Blood Pressure
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
Time frame: 2 weeks
Change in Morning Systolic Blood Pressure Variability
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
Time frame: 2 weeks
Changes in the Total Sleep Time
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
Time frame: 2 weeks
Changes in the Time to Sleep Onset
Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
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).
Time frame: 2 weeks
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Percentage change in UACR from baseline to 2 weeks
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
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).
Time frame: 2 weeks
Change in NT-proBNP
Percentage change in NT-proBNP from baseline to 2 weeks
Time frame: 2 weeks
| Milestone | Suvorexant | Placebo |
|---|---|---|
| Started | 40 | 42 |
| Completed | 40 | 42 |
| Not completed | 0 | 0 |
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
| mmHg | Suvorexant | Placebo |
|---|---|---|
| Change in Sleep Systolic Blood Pressure | -1.8 ± 2.7 | -4.4 ± 2.7 |
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
| mmHg | Suvorexant | Placebo |
|---|---|---|
| Change in Morning Systolic Blood Pressure Variability | -0.3 ± 1.5 | 0.8 ± 1.5 |
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
| hours | Suvorexant | Placebo |
|---|---|---|
| Changes in the Total Sleep Time | 0.51 ± 0.24 | 0.43 ± 0.25 |
Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
| hours | Suvorexant | Placebo |
|---|---|---|
| Changes in the Time to Sleep Onset | -0.23 ± 0.18 | -0.42 ± 0.15 |
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).
| mmHg | Suvorexant | Placebo |
|---|---|---|
| Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction | -6.1 ± 3.5 | 3.1 ± 4.2 |
Percentage change in UACR from baseline to 2 weeks
| percentage change | Suvorexant | Placebo |
|---|---|---|
| Change in Urinary Albumin-to-creatinine Ratio (UACR) | 1.50 (-15.18 to 21.45) | -13.12 (-27.22 to 3.71) |
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).
| mmHg | Suvorexant | Placebo |
|---|---|---|
| Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction | 4.5 ± 3.9 | -9.5 ± 3.1 |
Percentage change in NT-proBNP from baseline to 2 weeks
| percentage change | Suvorexant | Placebo |
|---|---|---|
| Change in NT-proBNP | 3.65 (-13.90 to 24.77) | -2.80 (-19.06 to 16.72) |
Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suvorexant | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Placebo | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(years) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Mean | 57.3 ± 12.1 | 55.9 ± 9.5 | 56.6 ± 10.8 |
| Sex: Female, Male(Participants) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 29 | 29 | 58 |
| Race and Ethnicity Not Collected(Participants) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m^2) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Mean | 25.5 ± 4.4 | 25.9 ± 3.9 | 25.7 ± 4.1 |
| Nighttime systolic blood pressure(mmHg) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Mean | 137.9 ± 15.9 | 140.7 ± 18.1 | 139.4 ± 17.0 |
| Nighttime diastolic blood pressure(mmHg) | Suvorexant | Placebo | Total |
|---|---|---|---|
| Mean | 80.5 ± 8.7 | 84.2 ± 10.2 | 82.4 ± 9.6 |
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Sleep Initiation and Maintenance Disorders→
Jichi Medical University