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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002752
Receipt No. R000003348
Scientific Title Renoprotective effect of combination therapy in hypertensive patients with renal diseases.
Date of disclosure of the study information 2009/11/12
Last modified on 2011/11/22

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Basic information
Public title Renoprotective effect of combination therapy in hypertensive patients with renal diseases.
Acronym Renoprotective effect of combination therapy in hypertensive patients with renal diseases.
Scientific Title Renoprotective effect of combination therapy in hypertensive patients with renal diseases.
Scientific Title:Acronym Renoprotective effect of combination therapy in hypertensive patients with renal diseases.
Region
Japan

Condition
Condition Hypertensive patients with renal diseases
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the effect of the combination therapy in hypertensive patients with renal diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Urinary protein excretion
2. Renal function
Key secondary outcomes 1. Blood pressure at office, home and 24 hours

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Addition of carcium channel blocker to angiotensin II receptor blocker
Interventions/Control_2 Addition of diuretics to angiotensin II receptor blocker
Interventions/Control_3 Angiotensin II receptor blocker only
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 Proteinuria equal or grater than (+) at dipstick test
Estimated glomerular filtration rate equal or grater than 30 ml/min/1.73m2
Systolic blood pressure equal or grater than 130 mmHg and/or diastolic blood pressure equal or grater than 80 mmHg, or under treatment with angiotensin II receptor blocker
Key exclusion criteria Uncontrolled hypertension (systolic blood pressure >200 mmHg)
No use of carcium channel blocker or diuretics within 1 month
Pregnancy or its possibility
Hypersensitivity to or contraindication of olmesartan
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Wada
Organization Kanazawa University Hospital
Division name Division of Nephrology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2499
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Furuichi
Organization Kanazawa University Hospital
Division name Division of Nephrology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Homepage URL
Email kfuruichi@m-kanazawa.jp

Sponsor
Institute Division of nephrology, Kanazawa University Hospital
Institute
Department

Funding Source
Organization Disease Control and Homeostasis, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of Medicine, Kanazawa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanazawa hypertension study group
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
2009 Year 11 Month 12 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 Preinitiation
Date of protocol fixation
2009 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2011 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003348

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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