UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000944 |
|---|---|
| Receipt number | R000001130 |
| Scientific Title | Effect of olmesartan on diurnal blood pressure profile, vascular function, oxidative stress, and renal renin-angiotensin system in hypertensives with chronic kidney disease |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2015/09/19 09:55:20 |
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Basic information
Public title
Effect of olmesartan on diurnal blood pressure profile, vascular function, oxidative stress, and renal renin-angiotensin system in hypertensives with chronic kidney disease
Acronym
Effects of olmesartan on hypertensives with CKD
Scientific Title
Effect of olmesartan on diurnal blood pressure profile, vascular function, oxidative stress, and renal renin-angiotensin system in hypertensives with chronic kidney disease
Scientific Title:Acronym
Effects of olmesartan on hypertensives with CKD
Region
| Japan |
Condition
Condition
Hypertension with chronic kidney disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
AT1 receptor blockers (ARBs) are known to improve glucose and lipid metabolism, and preserve renal and heart function, but there are few reports that investigate the mechanisms involved in these effects. The aim of this studu is to examine the possible effects of ARB (olmesartan) on diurnal blood pressure profile, renal function, vascular function, lipid metabolism, renal and heart function, oxidative stress markers, and thoses of intra-renal renin-angiotensin system in hypertensive patients with CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1) Abdominal circumference
2) Casual blood pressure, home blood pressure.
3) Diurnal blood pressure profile by ambulatory blood pressure monitoring.
4) Glucose metabolism: FPG, IRI, HbA1c.
5) Renal function: Urinary protein excretion, BUN, urinary creatinine excretion, urinary albumin excretion, eGFR, urinary type IV collagen excretion.
6) Lipid metabolism: total cholesterol, LDL cholesterol, tryglyceride, HDL-choresterol.
7) Cardiac function: BNP.
8) Vascular function: ABI/PWV, FMD.
9) Inflamation and oxidative stress marker: hs-CRP, adiponectin, plasma apelin, urinary 8-OHdG.
10) Markers of intra-renal renin-angiotensin system: plasma and urinary angiotensinogen.
11) Genotype of renin-angiotensin system: angiotensinogen, renin, AT1 receptor, ATRAP, Nedd4L.
12) Examination of renal biopsy specimen (glomerular sclerosis, fibrosis, and expression of ATRAP and AT1 receptor mRNA and protein).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan group: To achieve blood pressure control below 130/80 mmHg,
start with once-daily dosing of olmesartan 5-10 mg, and increase up to 10-40 mg if effect of olmesartan on the clinical parameters is insufficient.
If necessary, a combination therapy by several anti-hypertensives will be performed to achive casual blood pressure control below 130/80 mmHg.
Interventions/Control_2
Control group: To achieve blood pressure control below 130/80 mmHg,
start with anti-hypertensives including ACE inhibitor but other than ARBs, and increase dosage of respective anti-hypertensives if effect of first-line anti-hypertensives on the clinical parameters is insufficient. If necessary, a combination therapy by several anti-hypertensives will be performed to achive casual blood pressure control below 130/80 mmHg.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Casual Blood pressure >= 130/80.
2) Chronic kidney disease >= stage 1 (>= microalbunuria).
Key exclusion criteria
1) Pregnant women, or women suspected of being pregnant.
2) Hyperkalemia.
3) Bilateral renal artery stenosis.
4) History of hypersensitivity to the administered olmesartan.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Tamura |
Organization
Yokohama City University, Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuaki Uchino |
Organization
Yokohama City University Hospital
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2635
Homepage URL
mai_mew963@hotmail.com
Sponsor or person
Institute
Department of Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine
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
横浜市立大学附属病院 (Yokohama City University Hospital)
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001130
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