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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000729
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Akita Olmesartan renoprotection study group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000879

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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