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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000944
Receipt No. 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

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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
Email 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
Email mai_mew963@hotmail.com

Sponsor
Institute Department of Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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