UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000729 |
|---|---|
| Receipt number | R000000879 |
| Scientific Title | Comprison of the renoprotecrive and the antihypertensive effects of Olmesartan vs Losartan + low dose diuretics in normoalbuminuric diabetic patients |
| Date of disclosure of the study information | 2007/06/10 |
| Last modified on | 2009/12/04 15:06:41 |
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Basic information
Public title
Comprison of the renoprotecrive and the antihypertensive effects of Olmesartan vs Losartan + low dose diuretics in normoalbuminuric diabetic patients
Acronym
Evaluation of renoprotective effects of Olmesartan in normoalbuminuric diabetic patients
Scientific Title
Comprison of the renoprotecrive and the antihypertensive effects of Olmesartan vs Losartan + low dose diuretics in normoalbuminuric diabetic patients
Scientific Title:Acronym
Evaluation of renoprotective effects of Olmesartan in normoalbuminuric diabetic patients
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of Olmesartan vs Losartan + low dose diuretics on the renoprotective effects evaluating changes in urinary IgG, transferrin and ceruloplasmin excretions and blood pressure lowering effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. changes in urinary IgG, transferrin and ceruloplasmin excretions 2. blood pressure lowering effects.
Key secondary outcomes
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan (20mg)
Interventions/Control_2
Losartan (50mg) + hydrochlorothiazide (12.5mg) or trichlorothiazide (1mg)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. BP > 130 / 80 mmHg by losartan 50mg, telmisartan 20mg, valsartan 80mg or candesartan 8mg 2. All three consecutive spot urinary albumin measurements at outpatients' clinic within 1 year < 30mg /gCr
Key exclusion criteria
1. Past history of microalbuminuria, overt proteinuria or any kidney diseases 2. Pregnancy 3. Severe liver dysfunction 4. Cancer 5. Poor glycemic control (HbA1c > 10%) 6. Other reasons for exclusion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University School of Medicine
Division name
Endocrinology, diabetes and geriatric medicine
Zip code
Address
Hondo 1-1-1, Akita, Japan
TEL
018-884-6040
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University School of Medicine
Division name
Endocrinology, diabetes and geriatric medicine
Zip code
Address
Hondo 1-1-1, Akita, Japan
TEL
Homepage URL
Sponsor or person
Institute
Akita Olmesartan renoprotection study group
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2007 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2007 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 04 | Day |
Last modified on
| 2009 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000879
