HypertensionPhase 4Super1NCT02849184

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

A Phase 4 study testing suvorexant in people with Hypertension and Insomnia, run by Jichi Medical University at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypertension, Insomnia
What is being tested?: suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 3 sitesJapan
Study dates: 17 Jan 2017to Mar 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

[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

Show all 16Show fewer

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).
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.

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Takahira Internal Medicine Clinic
Fukuoka
Yamasaki family clinic
Hyōgo
Yagi hospital
Tokyo

Other trials in Japan

About this study

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

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.

Read the detailed description

The study consists of a 4-week run-in period and a 2-week treatment period.

Conditions: Hypertension, Insomnia
Being tested: suvorexant, Placebo
Medical subject headings: Hypertension, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

suvorexantDrug
Also called Belsomra
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
PlaceboOther
Placebo once daily before bedtime.

Study groups in NCT02849184
Study group	Role	What they receive
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 Receives: Drug: suvorexant
placebo	Placebo comparator	Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 weeks

Secondary outcomes (7)

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
Measured: 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
Measured: 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
Measured: 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).
Measured: 2 weeks
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Percentage change in UACR from baseline to 2 weeks
Measured: 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).
Measured: 2 weeks
Change in NT-proBNP
Percentage change in NT-proBNP from baseline to 2 weeks
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 2017Mar 2018

First posted29 Jul 2016 (estimated)
Study start17 Jan 2017
Primary completionOct 2017
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02849184
Sponsor's protocol ID: 4305-063
Acronym: Super1
Status last verified: Jun 2019
First submitted: 21 Jul 2016
Last updated: 5 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02849184
Acronym / sponsor ID: Super1 / 4305-063
Conditions: Hypertension, Insomnia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Jichi Medical UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, Satt Co.,Ltd
Study start: 17 Jan 2017 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 29 Jul 2016 (estimated)
Results: Posted 5 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
suvorexant	Experimental	Drug: suvorexantSuvorexant (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	Other: PlaceboPlacebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

[At interim registration]
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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
suvorexantAlso: BelsomraSuvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.	Drug	suvorexant
PlaceboPlacebo once daily before bedtime.	Other	placebo

Primary outcome

Change in Sleep Systolic Blood Pressure
Time frame: 2 weeks
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

7 secondary outcomes

Change in Morning Systolic Blood Pressure Variability
Time frame: 2 weeks
Changes in the Total Sleep Time
Time frame: 2 weeks
Changes in the Time to Sleep Onset
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
Time frame: 2 weeks
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
Time frame: 2 weeks
Change in NT-proBNP
Time frame: 2 weeks

Results and safety

Results posted to the registry on 5 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suvorexant	40	40
Placebo	42	42

Primary outcome: Change in Sleep Systolic Blood Pressure

Time frame: 2 weeks. Mean (Standard Error). Unit: mmHg

Measure	Suvorexant n = 40	Placebo n = 42
Value	-1.8 (2.7)	-4.4 (2.7)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suvorexant	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Placebo	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kazuomi Kario, MD, PhD principal investigator

Jichi Medical University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing suvorexant in people with Hypertension and Insomnia, run by Jichi Medical University at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sleep Systolic Blood Pressure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.