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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000442
Receipt No. R000000538
Scientific Title Effects of 5 ARBs on blood pressure, glucose and lipid metabolism, renal and heart function, and inflammation markers (Earnest)
Date of disclosure of the study information 2006/07/05
Last modified on 2012/07/10

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Basic information
Public title Effects of 5 ARBs on blood pressure, glucose and lipid metabolism, renal and heart function, and inflammation markers (Earnest)
Acronym Earnest
Scientific Title Effects of 5 ARBs on blood pressure, glucose and lipid metabolism, renal and heart function, and inflammation markers (Earnest)
Scientific Title:Acronym Earnest
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

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 compare clinical differences in these effects among multiple ARBs. The aim of this study is to compare effects of 5 ARBs (losartan, telmisartan, candesartan, valsartan, and olmesartan) on blood pressure, glucose and lipid metabolism, renal and heart function, and inflammation markers in patients with hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1. Waist circumference
2. Blood pressure, Ambulatory blood pressure
3. FPG, IRI, HbA1c, (IRI, PG during OGTT)
4. Proteinuria, albuminuria, urinary creatinine, BUN
5. TC (or LDL-C), TG, HDL-C
6. BNP
7. hs-CRP, adiponectin
8. baPWV
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Losartan group
Start with once-daily dosing of losartan 25-50 mg, and increase up to 50-100 mg if effect of losartan on the clinical parameters is insufficient.
Interventions/Control_2 Telmisartan group
Start with once-daily dosing of telmisartan 20-40 mg, and increase up to 40-80 mg if effect of telmisartan on the clinical parameters is insufficient.
Interventions/Control_3 Candesartan group
Start with once-daily dosing of candesartan 4-8 mg, and increase up to 8-12 mg if effect of candesartan on the clinical parameters is insufficient.
Interventions/Control_4 Valsartan group
Start with once-daily dosing of valsartan 40-80 mg, and increase up to 80-160 mg if effect of valsartan on the clinical parameters is insufficient.
Interventions/Control_5 Olmesartan group
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.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Blood pressure >= 140/90
>= 130/80 for patients with diabetes or chronic kidney diseases
Key exclusion criteria Patients already receiving ARBs
Pregnant women, or women suspected of being pregnant
Hyperkalemia
Bilateral renal artery stenosis
Patients with history of hypersensitivity to the administered ARB
Patients with severe liver disorder (losartan)
Patients with severe defect in biliary drainage from liver or severe hepatic disorder (telmisartan)
Target sample size 300

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

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki Uchino
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
Homepage URL
Email uchinok@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
Department of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
Department of Endocrinology and Metabolism
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

Other administrative information
Date of disclosure of the study information
2006 Year 07 Month 05 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
Date of protocol fixation
2006 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 04 Day
Last modified on
2012 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000538

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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