UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016166
Receipt number 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 11:28:40

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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 or person

Institute

Osaka university graduate school of medicine
The departent of geriatric medicine and nephrology

Institute

Department

Personal name



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

Value
https://center6.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