UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000442 |
|---|---|
| Receipt number | 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 14:16:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
uchinok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
Department of Endocrinology and Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.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 |
