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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008841
Receipt No. R000010361
Scientific Title Evaluation of renoprotective and hypotensive effects by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Date of disclosure of the study information 2012/09/03
Last modified on 2017/09/08

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Basic information
Public title Evaluation of renoprotective and hypotensive effects by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Acronym Evaluation of renoprotective and hypotensive effects by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Scientific Title Evaluation of renoprotective and hypotensive effects by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Scientific Title:Acronym Evaluation of renoprotective and hypotensive effects by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of renoprotective and hypotensive effects and safety by combined use of irbesartan and amlodipine besilate in elderly patients with hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of clinical and laboratory data before and after the start of combination therapy.
Key secondary outcomes

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 Irbesartan, Amlodipine besilate
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with age of 75 years and more.
2)Male or female.
3)Outpatient or hospitalization.
4)Hypertension;
Patient uses amlodipine or ARB for one month or more,
In hospital, patient with systolic blood pressure of 140 mmHg and more, or diastolic blood pressure of 90 mmHg and more.
In home, patient with systolic blood pressure of 135 mmHg and more, or diastolic blood pressure of 85 mmHg and more.
Key exclusion criteria 1)Patients with hypersensitivity for the study drugs.
2)Patients with bilateral renal artery stenosis.
3)Patients with hyperkalemia.
4)Patients with eGFR value of 29 mL/min/1.73m2 or less.
5)Patients who uses of corticosteroid and/or immunosuppressant.
6)Patients who are considered to be inappropriate by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeto Morimoto
Organization Kanazawa Medical University
Division name Geriatric Medicine
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa Medical University
Division name Geriatric Medicine
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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
2012 Year 09 Month 03 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
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 03 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
2012 Year 09 Month 03 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/09/08 終了報告書.pdf


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