UMIN-CTR Clinical Trial

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 &#8804; 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
Email

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
Email	konosita@u-fukui.ac.jp

Sponsor
Institute	GENOMIC DISEASE OUTCOME CONSORTIUM (G-DOC) STUDY INVESTIGATORS
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006625