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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016166
Receipt No. R000018762
Scientific Title The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Date of disclosure of the study information 2015/01/09
Last modified on 2018/07/18

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Basic information
Public title The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Acronym The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Scientific Title The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Scientific Title:Acronym The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of telmisartan in autonomic function in the hypertensive patients with obstructive sleep apnea who is unavailable on continuous positive airway pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes autonomic function
Key secondary outcomes 1)polysomnography
2)blood pressure, pulse rate
3)index of oxidative stress

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 20mg, 40mg or 80mg of telmisartan
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 with obstructive sleep apnea
2)The untreated hypertensive patients with BP beyond 140/90mmHg, or the uncontrolled hypertensive patients treated with single antihypertensive drugs other than RAS blockades (renin inhibitor, ACE inhibitor, ARB, aldosterone blocker).
3)Patients unavailable on continuous positive airway pressure for any reason.
Key exclusion criteria 1)The subjects who have past medical history of hypersensitivity to telmisartan
2)The subjects during pregnancy or lactation
3)The subjects found offensive by attending physicians for this research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihisa Ito
Organization Osaka university graduate school of medicine
Division name The departent of geriatric medicine and nephrology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3852
Email itoh@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Ito
Organization Osaka university graduate school of medicine
Division name The departent of geriatric medicine and nephrology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3852
Homepage URL
Email itoh@geriat.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
The departent of geriatric medicine and nephrology
Institute
Department

Funding Source
Organization Osaka university graduate school of medicine
The departent of geriatric medicine and nephrology
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
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
2015 Year 01 Month 09 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
2015 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 09 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 09 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018762

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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