UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007350 |
|---|---|
| Receipt number | R000008658 |
| Scientific Title | Effects on Blood Pressure, Cardio-Renal Function and Vascular Endothelial Function by HyperUricemia Treatment Study |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2012/02/21 19:53:29 |
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Basic information
Public title
Effects on Blood Pressure, Cardio-Renal Function and Vascular Endothelial Function by HyperUricemia Treatment Study
Acronym
Effects on Blood Pressure, Cardio-Renal Function and Vascular Endothelial Function by HyperUricemia Treatment Study
(HUT Study)
Scientific Title
Effects on Blood Pressure, Cardio-Renal Function and Vascular Endothelial Function by HyperUricemia Treatment Study
Scientific Title:Acronym
Effects on Blood Pressure, Cardio-Renal Function and Vascular Endothelial Function by HyperUricemia Treatment Study
(HUT Study)
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of hyperuricemia treatment; febuxostat, inhibitor of xanthine oxidase on blood pressure, cardio-renal function, vascular endothelial function, arteriosclerosis, uric acid, sugar and lipid metabolism by multicenter prospective trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Vascular endothelial function(flow mediated dilatation, pulse wave velocity, carotid intima-media thickness)
2. Cardio-renal function(NT-pro BNP, estimated GFR, cardiac echography)
3. Blood pressure
Key secondary outcomes
1. The change of serum uric acid
2. Ankle brachial index
3. Cytokine: 9-OhdG, MDA-LDL, CRP, IL-6, AGE, RAGE, NOx, Angintensin2, ADMA, IGF-alpha
4. Blood sugar, insulin, HbA1c, HOMA-beta
5. LDL-cholesterol, HDL-cholesterol, trigliceride
6. Blood test: BUN, creatinine, AST, ALT, LDH, ALP, sodium, potacium, cloride, homocystein
7. Urine test: uric acid, creatinin, sodium, potacium, cloride
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Febuxostat 10mg once a day for 2 weeks.
Febuxostat 20mg once a day after 2 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hyperuricemia patients eligible for all the points of the following:
(1) Japanese male or female, 20 years old or above at the time of informed consent
(2) Serum uric acid > 8.0mg/dL
(3) Not treated with uric acid lowering agent within 3 month before the timing of eligibility judgement
(4) Patients enable to measure vascular endotherial function
(5) Patinets from which informed consent is obtained
Key exclusion criteria
(1)Patients having anti-hyperuricemia medication
(2)Patients with hypersensitivity to febuxostat
(3)HbA1c is 8% and over
(4)Patients with medication including NO donor
(5)Hepatic impairment patients (AST, ALT is more than double of standard values)
(6)Pregnant female, lactation femal, hoping gestation
(7)Patients with corticosteroid 10mg/day and over
(8)Treated patients with mercaptopurine or azathioprine
(9)Patints having malignancy
(10)Patients whom study physicians consider as not eligible.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Niwa Koichiro |
Organization
St.Lukes International Hospital
Division name
Department of Cardiology
Zip code
Address
9-1 Akashi-cho, Tyuuou-ku, Tokyo
TEL
03-3541-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuwabara Masanari |
Organization
St. Lukes International Hospital
Division name
Department of Cardiology
Zip code
Address
9-1 Akashi-cho, Tyuuou-ku, Tokyo
TEL
03-3541-5151
Homepage URL
kuwamasa728@ybb.ne.jp
Sponsor or person
Institute
St. Lukes International Hospital
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization
Other
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
聖路加国際病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2012 | Year | 02 | Month | 21 | Day |
Last modified on
| 2012 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008658
