UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of telmisartan in hypertensive patients with obstructive sleep apnea
Title of the study (Brief title)	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	Norihisa Ito
Organization	Osaka university graduate school of medicine
Division name	The departent of geriatric medicine and nephrology
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	Norihisa Ito
Organization	Osaka university graduate school of medicine
Division name	The departent of geriatric medicine and nephrology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018762