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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012816
Receipt No. R000014974
Scientific Title The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Date of disclosure of the study information 2014/01/20
Last modified on 2014/01/10

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Basic information
Public title The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Acronym The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Scientific Title The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Scientific Title:Acronym The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether azilsartan is superior to amlodipine in terms of improvement in exercise capacity with functional therapy in hypertensive patients with sarcopenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)Muscle strength of lower limbs
(2)Muscle mass of appendicular skeletal muscle.
(3)ABPM
(4)Serum concentration of angiotensin 1-7
Key secondary outcomes Serum myokine concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 azilsartan
Interventions/Control_2 amlodipine
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Hypertensive patients, 65yeas of age and older
(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) Muscle mass of appendicular skeletal muscle measured by BIA methods less than 7.0kg//m2 in male, 5.8kg/m2 in female
Key exclusion criteria (1) The subjects found difficult to perform functional therapy because of prior stroke or orthopedic disease.
(2) The subjects who have past medical history of hypersensitivity to azilsartan or amlodipine
(3) The subjects found offensive by attending physicians for this research
Target sample size 40

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

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

Sponsor
Institute Geriatric medicine and nephrology, Osaka university Graduate school of medicine
Institute
Department

Funding Source
Organization Geriatric medicine and nephrology, Osaka university Graduate school of medicine
Organization
Division
Category of Funding Organization
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 大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2014 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014974

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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