UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004300 |
|---|---|
| Receipt number | R000005140 |
| Scientific Title | Anti-Hypertensive treatment of Nephrosclerosis in Elderly |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2016/10/04 17:23:15 |
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Basic information
Public title
Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Acronym
Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Scientific Title
Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Scientific Title:Acronym
Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Region
| Japan |
Condition
Condition
Nephrosclerosis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare reno-protective effects of olmesaltan with or without azelnidipine in nephroscrelosis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change of estimated GFR before and after the treatment
Key secondary outcomes
Change of following paparemters before and after the treatment
(1) 1/serum creatinine concetration
(2) Office blood pressure
(3) heart rate
(4) urinary albumin excretion
(5) serum concentrations of BUN, cystatin C, and hs-CRP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After observation period for 4 weeks with 20mg of olmesartan, participants were randomly assigned to a group treated with 40mg of olmesartan for 52 weeks.
Interventions/Control_2
After observation period for 4 weeks with 20mg of olmesartan, participants were randomly assigned to a group treated with 20mg of olmesartan plus 16mg of azelnidipine for 52 weeks.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Participants who gave written informed consent.
(2) Outpatients
(3)Systolic blood pressure at clinic is more than 140 mmHg or diastolic pressure is more than 90 mmHg
(4)Serum HbA1c concentration is less than 6.0
(5)urinary albumin excretion is less than 1g/g.Cr.
(6)Patients treated with RAS-inhibitor but not with Ca channel blocker for 2 months just before initiation of the study.
Key exclusion criteria
1. Hypertensive crisis
2. Hyperkalemia (serum potassium conc.>5.5mM)
3. renal failure (eGFR<30ml/min/1.73m2)
4. bilateral renal artery stenosis
5. newly onset of stroke (within 6 months just before entry)
6. severe congestive heart failure (more than NYHA class III)
7. liver dysfunction (AST/ALT concentration is 5 fold higher than normal range)
8. newly onset of acute myocardial infarction.
9. Malignancy
10. Patients who had severe adverse reactions by Ca channel blockers of RAS inhibitors.
11. Patients who are prescribed immunosuppressant or glucocorticoids.
12. Patients who are prescribed NSAIDs for long time (more than 2 weeks).
13. Patients whose doctors determined as inadequate for the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamagata |
Organization
University of Tsukuba
Division name
Nephrology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Saito |
Organization
University of Tsukuba
Division name
Nephrology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
Homepage URL
chie.saito@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Nephrology, University of Tsukuba.
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, University of Tsukuba.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
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
1. いなしきクリニック（茨城県）
2. 医療法人 桜雄会 塚田整形外科（茨城県）
3. 医療法人社団 光栄会 田谷医院（茨城県）
4. 医療法人 慈厚会 野上病院（茨城県）
5. 医療法人 道淑会 高野医院（茨城県）
6. 医療法人社団 厚真会 ごとう内科（茨城県）
7. 医療法人社団 桜井内科医院（茨城県）
8. 医療法人社団 三輪会 山手医院（茨城県）
9. かしむら内科消化器科クリニック（茨城県）
10. 医療法人新岳会 研究学園クリニック（茨城県）
11. なかの循環器クリニック（茨城県）
12. なるしま内科医院（茨城県）
13. 南大通りクリニック （茨城県）
14. 宮﨑クリニック（茨城県）
15. やまぐち医院（茨城県）
16. いとう内科胃腸科医院（茨城県）
17. 中島医科歯科クリニック（茨城県）
18. 医療法人社団 しば医院（茨城県）
19. 海老原医院（茨城県）
20. 桜橋クリニック（茨城県）
21. 筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 30 | Day |
Last modified on
| 2016 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005140
