UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012816
Receipt number 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 20:13:27

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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 or person

Institute

Geriatric medicine and nephrology, Osaka university Graduate school of medicine

Institute

Department

Personal name



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

Value
https://center6.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