UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007057 |
|---|---|
| Receipt number | 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 22:11:15 |
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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
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
meiyou2.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical & Dental University, Graduate School of Medical and Dental Sciences, Department of Sleep Modulatory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008201
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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