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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004300 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Nephrosclerosis | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Nephrology, University of Tsukuba. |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005140 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |