Unique ID issued by UMIN | UMIN000023389 |
---|---|
Receipt number | 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 09:53:16 |
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
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
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
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
Japan |
Insomnia with hypertensive symptoms
Cardiology |
Others
NO
To compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension.
Safety,Efficacy
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).
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.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
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.
During the treatment period (2 weeks), the patients will orally receive placebo once daily before bedtime.
20 | years-old | <= |
Not applicable |
Male and Female
[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.
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
80
1st name | |
Middle name | |
Last name | Kazuomi Kario |
Jichi Medical University School of Medicine
Division of Cardiovascular Medicine, Department of Medicine,
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
0285-58-7538
kkario@jichi.ac.jp
1st name | |
Middle name | |
Last name | Secretariat |
Satt Co., Ltd.
Clinical research steering group
ACN Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
03-5312-5026
super1@sa-tt.co.jp
Jichi Medical University School of Medicine
MSD K.K.
Profit organization
NO
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).
2016 | Year | 08 | Month | 12 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 16 | Day |
2017 | Year | 01 | Month | 17 | Day |
2016 | Year | 07 | Month | 29 | Day |
2018 | Year | 03 | Month | 26 | Day |
Value
https://center6.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 |