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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023389
Receipt No. R000026687
Scientific 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 insomniacs with hypertension: The Super 1 study
Date of disclosure of the study information 2016/08/12
Last modified on 2018/03/26

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Basic information
Public 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 insomniacs with hypertension: The Super 1 study
Acronym A multi-center, double-blind, randomized, parallel design study to compare the effectiveness of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension: The Super 1 study
Scientific 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 insomniacs with hypertension: The Super 1 study
Scientific Title:Acronym A multi-center, double-blind, randomized, parallel design study to compare the effectiveness of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension: The Super 1 study
Region
Japan

Condition
Condition Insomnia with hypertensive symptoms
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint:
To compare the efficacy of suvorexant versus placebo on the reduction of sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM).
Key secondary outcomes Secondary endpoints:
1. To compare the percent change from non-dippers to dippers.
2. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP by ABPM and HBPM.
3. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP variability by ABPM and HBPM.
4. Changes in the total sleep time (TST) (self-reported).
5. Changes in the time to sleep onset (TSO) (self-reported).
6. To study the correlation of changes of sleep BP parameters with changes of sleep quality parameters
7. To study the correlation of changes of urinary albumin-to-creatinine ratio (UACR) / NT-proBNP.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 During the treatment period (2 weeks), the patients will orally receive suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Interventions/Control_2 During the treatment period (2 weeks), the patients will orally receive placebo once daily before bedtime.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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:
a. Under antihypertensive medications
b. Clinic systolic blood pressure (SBP) less than 160 mmHg
6) Patients with insomnia who meet at least one of the following:
a. 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.
Key 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
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine,
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Secretariat
Organization Satt Co., Ltd.
Division name Clinical research steering group
Zip code
Address ACN Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-5312-5026
Homepage URL
Email super1@sa-tt.co.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団慈光会 八木病院(東京都)、やまさきファミリークリニック(兵庫)、たかひら内科クリニック(福岡).

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 29 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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