Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Satt Co.,Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| placebo | Placebo Comparator | Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suvorexant | Drug | Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Changes in the Total Sleep Time |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kazuomi Kario, MD, PhD | Jichi Medical University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takahira Internal Medicine Clinic | Fukuoka | Japan | ||||
| Yamasaki family clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant | Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime. |
| FG001 | Placebo | Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks. Placebo: Placebo once daily before bedtime. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant | Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | mmHg | 2 weeks |
|
14 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suvorexant | Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Kazuomi Kario | Jichi Medical University School of Medicine | +81-285-58-7538 | kkario@jichi.ac.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2016 | Jun 16, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
Not provided
Not provided
| ID | Term |
|---|---|
| C551624 | suvorexant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo once daily before bedtime. |
|
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
| 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 | 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). | 2 weeks |
| Change in Urinary Albumin-to-creatinine Ratio (UACR) | Percentage change in UACR from baseline to 2 weeks | 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). | 2 weeks |
| Change in NT-proBNP | Percentage change in NT-proBNP from baseline to 2 weeks | 2 weeks |
| Hyōgo |
| Japan |
| Yagi hospital | Tokyo | Japan |
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks. Placebo: Placebo once daily before bedtime. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Nighttime systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Nighttime diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | mmHg | 2 weeks |
|
|
|
| Secondary | Changes in the Total Sleep Time | Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0 | Posted | Mean | Standard Error | hours | 2 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | hours | 2 weeks |
|
|
|
| Secondary | 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). | Patients who were satisfied with sleep as of 2 weeks | Posted | Mean | Standard Error | mmHg | 2 weeks |
|
|
|
| Secondary | Change in Urinary Albumin-to-creatinine Ratio (UACR) | Percentage change in UACR from baseline to 2 weeks | Posted | Median | 95% Confidence Interval | percentage change | 2 weeks |
|
|
|
| Secondary | 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). | Patients who were not satisfied with sleep as of 2 weeks | Posted | Mean | Standard Error | mmHg | 2 weeks |
|
|
|
| Secondary | Change in NT-proBNP | Percentage change in NT-proBNP from baseline to 2 weeks | Posted | Median | 95% Confidence Interval | percentage change | 2 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks. Placebo: Placebo once daily before bedtime. | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |