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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007057
Receipt No. R000008201
Scientific Title The effect of chronotherapy with the angiotensin-antagonist in hypertension with sleep apnea syndrome.
Date of disclosure of the study information 2012/01/12
Last modified on 2018/10/10

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Basic information
Public title The effect of chronotherapy with the angiotensin-antagonist in hypertension with sleep apnea syndrome.
Acronym The effect of chronotherapy with the angiotensin-antagonist in hypertension with sleep apnea syndrome.
Scientific Title The effect of chronotherapy with the angiotensin-antagonist in hypertension with sleep apnea syndrome.
Scientific Title:Acronym The effect of chronotherapy with the angiotensin-antagonist in hypertension with sleep apnea syndrome.
Region
Japan

Condition
Condition Sleep Apnea Syndrome
Classification by specialty
Medicine in general Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact on the circadian pattern of blood pressure on modifying the time of ARB treatment, body weight, insulin resistance and metabolic markers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Blood pressure
Key secondary outcomes Heart rate, Urine albumin, CRP, Body weight/Waist circumference, Adiponectin

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We randomly assign hypertensive patients with sleep apnea to treatment with irbesartan, 100mg daily, with morning administration or with evening administration for 24 weeks. After 12 weeks, each administration protocol is switched according to a crossover design.
Interventions/Control_2 We randomly assign hypertensive patients with sleep apnea to treatment with irbesartan, 100mg daily, with morning administration or with evening administration for 24 weeks. After 12 weeks, each administration protocol is switched according to a crossover design.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patient with sleep apnea syndrome treated with oral appliance or nasal CPAP.
2. Hypertensive patient diagnosed by JSH 2009.
3. Patient should be treated with good compliance by oral appliance or nasal CPAP (usage: >=4 hours daily and >=5 days)
Key exclusion criteria 1. Patient from whom written informed consent is not obtained.
2. Not hypertensive patient.
3. Patient who has the hypersensitivity to irbesartan.
4. Pregnant woman and possible possible pregnant woman.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meiyo Tamaoka
Organization Tokyo medical and dental university
Division name Graduate School of Medical and Dental Sciences
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN
TEL 81-3-5803-4967
Email meiyou2.pulm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Meiyo Tamaoka
Organization Tokyo Medical & Dental University
Division name University Hospital of Medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 81-3-5803-4967
Homepage URL http://www.tmd.ac.jp/med/pulm/sleep/index.html
Email meiyou2.pulm@tmd.ac.jp

Sponsor
Institute Tokyo Medical & Dental University, Graduate School of Medical and Dental Sciences, Department of Sleep Modulatory Medicine
Institute
Department

Funding Source
Organization Tokyo Medical & Dental University, Graduate School of Medical and Dental Sciences, Department of Sleep Modulatory Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2012 Year 01 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
2011 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2015 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 12 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008201

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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