UMIN-CTR Clinical Trial

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

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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 or person

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name



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

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