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
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
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
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
