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To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia (Super1)

Primary Purpose

Hypertension, Insomnia

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
suvorexant
Placebo
Sponsored by
Jichi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    • Under antihypertensive medications
    • Clinic systolic blood pressure (SBP) less than 160 mmHg

  6. 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:

  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:

  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

Sites / Locations

  • Takahira Internal Medicine Clinic
  • Yamasaki family clinic
  • Yagi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

suvorexant

placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Changes in the Total Sleep Time
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
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
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).
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Percentage change in UACR from baseline to 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).
Change in NT-proBNP
Percentage change in NT-proBNP from baseline to 2 weeks

Full Information

First Posted
July 21, 2016
Last Updated
June 16, 2019
Sponsor
Jichi Medical University
Collaborators
Merck Sharp & Dohme LLC, Satt Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02849184
Brief Title
To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia
Acronym
Super1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jichi Medical University
Collaborators
Merck Sharp & Dohme LLC, Satt Co.,Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The study consists of a 4-week run-in period and a 2-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suvorexant
Arm Type
Experimental
Arm Description
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Intervention Type
Drug
Intervention Name(s)
suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily before bedtime.
Primary Outcome Measure Information:
Title
Change in Sleep Systolic Blood Pressure
Description
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
Secondary Outcome Measure Information:
Title
Change in Morning Systolic Blood Pressure Variability
Description
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
Title
Changes in the Total Sleep Time
Description
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
Time Frame
2 weeks
Title
Changes in the Time to Sleep Onset
Description
Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
Time Frame
2 weeks
Title
Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
Description
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
Title
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Description
Percentage change in UACR from baseline to 2 weeks
Time Frame
2 weeks
Title
Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
Description
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
Title
Change in NT-proBNP
Description
Percentage change in NT-proBNP from baseline to 2 weeks
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuomi Kario, MD, PhD
Organizational Affiliation
Jichi Medical University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Takahira Internal Medicine Clinic
City
Fukuoka
Country
Japan
Facility Name
Yamasaki family clinic
City
Hyogo
Country
Japan
Facility Name
Yagi hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia

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