UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005612 |
|---|---|
| Receipt number | R000006625 |
| Scientific Title | Genetic-Disease Outcome Consortium-Aliskiren Study |
| Date of disclosure of the study information | 2011/05/17 |
| Last modified on | 2019/11/22 14:21:29 |
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Basic information
Public title
Genetic-Disease Outcome Consortium-Aliskiren Study
Acronym
G-DOC-ALIS Study
Scientific Title
Genetic-Disease Outcome Consortium-Aliskiren Study
Scientific Title:Acronym
G-DOC-ALIS Study
Region
| Japan |
Condition
Condition
Hypertension with Diabetes Mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Comparison of anti-albuminuric effects on hypertensives with diabetes mellitus between aliskiren and amlodipine on top of ARB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Reduction rate of urinary albumin/creatinine ratio (UACR) from baseline after 24 weeks
Key secondary outcomes
Remission rate: subjects rate obtaining UACR < 30 mg/gCr
Regression rate: subjects rate obtaining UACR ≤ 50% of baseline
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 considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren arm: Administer aliskiren on top of maximum dose of ARB with target blood pressure of 130/80 mmHg (total 24 weeks). Start with 150mg aliskiren daily and dose up to 300mg. In the case of insufficient depressor effects, first, diuretics and then alpha-blocker may be added.
Interventions/Control_2
Amlodipine arm: Administer amlodipine on top of maximum dose of ARB with target blood pressure of 130/80 mmHg (total 24 weeks). Start with 5mg amlodipine daily and dose up to 10mg. In the case of insufficient depressor effects, first, diuretics and then alpha-blocker may be added.
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
Hypertensives with diabetes mellitus with UACR 50-500 mg/gCr
Key exclusion criteria
1) HbA1c>9%
2) Serum Kalium>5.2mEq/l
3) eGFR<30ml/min/1.73m2
4) Other trial drugs within 30 days
5) Treated with aldosterone blockers or ARB
6) Acute Heart Failure
7) Chronic liver disease, malignant hypertension, stroke, acute coronary syndrome, acute myocardial infarction, PCI or angioplasty within 3 months
8) Pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Konoshita |
Organization
Fukui University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, 910-1193, Japan
TEL
0776-61-8353
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Konoshita |
Organization
Fukui University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, 910-1193, Japan
TEL
0776-61-8353
Homepage URL
konosita@u-fukui.ac.jp
Sponsor or person
Institute
GENOMIC DISEASE OUTCOME CONSORTIUM (G-DOC) STUDY INVESTIGATORS
Institute
Department
Personal name
Funding Source
Organization
Fukui University School of Medicine
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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | 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=R000006625
| 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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| Registered date | File name |
