UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008841 |
|---|---|
| Receipt number | 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 15:45:27 |
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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
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
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010361
