UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of suvorexant in circadian rhythm of blood pressure in hypertensive patients with insomnia
Title of the study (Brief title)	ESCAPE Study
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Medicine in general Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the improvements of circadian rhythm of blood pressure, early-morning and nocturnal hypertension with the improvement of insomnia by suvorexant in hypertensive patients with insomnia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Circadian rhythm of blood pressure
Key secondary outcomes	Early-morning blood pressure Nocturnal blood pressure Office blood pressure Changes in biochemical parameters Adverse effects

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hypertensive patients with insomnia are enrolled. The patients receive suvorexant (20 mg/day at night) for 4 weeks. If the patients are elderly, they receive suvorexant (15 mg/day at night) for 4 weeks.
Interventions/Control_2
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	1.Patients who had the levels of fasting triglyceride more than 150 mg/dl. 2.Age is 20 years old or more and gender is male or female. 3.Patinets who did not have sleeping pills. 4.Patients who gave their written informed consent to participate for the present study.
Key exclusion criteria	1.Severe cardiac failure. 2.Severe liver dysfunction. 3.Severe renal dysfunction. 4.Pregnancy or lactation in women. 5.Patients with a history of allergy to any component of the study medications. 6.Ineligible patients according to the judgment by physician.
Target sample size	10

Research contact person
Name of lead principal investigator	Keijiro Saku
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Email	miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	Shin-ichiro Miura
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Homepage URL
Email	miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute	Department of Cardiology,Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Department of Cardiology,Fukuoka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	福岡大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 06 Month 20 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 24 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020637