Trial Outcomes & Findings for To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia (NCT NCT02849184)
NCT ID: NCT02849184
Last Updated: 2019-08-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-08-05
Participant Flow
Participant milestones
| Measure |
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.
|
Placebo
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
|
Overall Study
COMPLETED
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 12.1 • n=40 Participants
|
55.9 years
STANDARD_DEVIATION 9.5 • n=42 Participants
|
56.6 years
STANDARD_DEVIATION 10.8 • n=82 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=40 Participants
|
13 Participants
n=42 Participants
|
24 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=40 Participants
|
29 Participants
n=42 Participants
|
58 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
25.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=40 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 3.9 • n=42 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 4.1 • n=82 Participants
|
|
Nighttime systolic blood pressure
|
137.9 mmHg
STANDARD_DEVIATION 15.9 • n=40 Participants
|
140.7 mmHg
STANDARD_DEVIATION 18.1 • n=42 Participants
|
139.4 mmHg
STANDARD_DEVIATION 17.0 • n=82 Participants
|
|
Nighttime diastolic blood pressure
|
80.5 mmHg
STANDARD_DEVIATION 8.7 • n=40 Participants
|
84.2 mmHg
STANDARD_DEVIATION 10.2 • n=42 Participants
|
82.4 mmHg
STANDARD_DEVIATION 9.6 • n=82 Participants
|
PRIMARY outcome
Timeframe: 2 weeksTo 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
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in Sleep Systolic Blood Pressure
|
-1.8 mmHg
Standard Error 2.7
|
-4.4 mmHg
Standard Error 2.7
|
SECONDARY outcome
Timeframe: 2 weeksTo compare the efficacy of suvorexant versus placebo on morning SBP variability by ABPM Variability: SD Change: value at 2 weeks minus value at baseline
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in Morning Systolic Blood Pressure Variability
|
-0.3 mmHg
Standard Error 1.5
|
0.8 mmHg
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 2 weeksTotal sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Changes in the Total Sleep Time
|
0.51 hours
Standard Error 0.24
|
0.43 hours
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 2 weeksTime to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Changes in the Time to Sleep Onset
|
-0.23 hours
Standard Error 0.18
|
-0.42 hours
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Patients who were satisfied with sleep as of 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).
Outcome measures
| Measure |
Suvorexant
n=24 Participants
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.
|
Placebo
n=17 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
|
-6.1 mmHg
Standard Error 3.5
|
3.1 mmHg
Standard Error 4.2
|
SECONDARY outcome
Timeframe: 2 weeksPercentage change in UACR from baseline to 2 weeks
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in Urinary Albumin-to-creatinine Ratio (UACR)
|
1.50 percentage change
Interval -15.18 to 21.45
|
-13.12 percentage change
Interval -27.22 to 3.71
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Patients who were not satisfied with sleep as of 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 2weeks. Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).
Outcome measures
| Measure |
Suvorexant
n=16 Participants
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.
|
Placebo
n=25 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
|
4.5 mmHg
Standard Error 3.9
|
-9.5 mmHg
Standard Error 3.1
|
SECONDARY outcome
Timeframe: 2 weeksPercentage change in NT-proBNP from baseline to 2 weeks
Outcome measures
| Measure |
Suvorexant
n=40 Participants
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.
|
Placebo
n=42 Participants
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Placebo: Placebo once daily before bedtime.
|
|---|---|---|
|
Change in NT-proBNP
|
3.65 percentage change
Interval -13.9 to 24.77
|
-2.80 percentage change
Interval -19.06 to 16.72
|
Adverse Events
Suvorexant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Kazuomi Kario
Jichi Medical University School of Medicine
Phone: +81-285-58-7538
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60