UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002752 |
|---|---|
| Receipt number | 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 10:24:45 |
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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
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
kfuruichi@m-kanazawa.jp
Sponsor or person
Institute
Division of nephrology, Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003348
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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