UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018063 |
|---|---|
| Receipt number | R000020637 |
| Scientific Title | Effect of suvorexant in circadian rhythm of blood pressure in hypertensive patients with insomnia |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2019/02/14 17:53:38 |
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Basic information
Public title
Effect of suvorexant in circadian rhythm of blood pressure in hypertensive patients with insomnia
Acronym
ESCAPE Study
Scientific Title
Effect of suvorexant in circadian rhythm of blood pressure in hypertensive patients with insomnia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University Hospital
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
miuras@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Miura |
Organization
Fukuoka University Hospital
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
Homepage URL
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology,Fukuoka University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020637
