UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010222 |
|---|---|
| Receipt number | R000011304 |
| Scientific Title | The establishment of the effective treatment for hyperuricemia in hypertensive patient with hyperuricemia |
| Date of disclosure of the study information | 2013/03/12 |
| Last modified on | 2013/03/12 17:34:40 |
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Basic information
Public title
The establishment of the effective treatment for hyperuricemia in hypertensive patient with hyperuricemia
Acronym
The treatment for hyperuricemia
Scientific Title
The establishment of the effective treatment for hyperuricemia in hypertensive patient with hyperuricemia
Scientific Title:Acronym
The treatment for hyperuricemia
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The established of the effective treatment for hyperuricemia in hypertensive patient with hyperuricemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum uric acid, uric acid clearance, adverse event
Key secondary outcomes
blood pressure. renal function,
oxidant stress, endothelial function, renal artery resistance, inflammation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.febuxostat40mg
2.febuxostat20mg+benzbromarone25mg
3.benzbromarone50mg
Interventions/Control_2
1.benzbromarone50mg
2.febuxostat20mg+benzbromarone25mg
3.febuxostat40mg
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hypertensive patients with hyperuricemia, whose serum uric acid level >8 mg/dL on untreated or serum uric acid level >6 mg/dL in spite of taking UA lowering drugs over three months.
Key exclusion criteria
resistant hypertensive patient (SBP>=180mmHg or DBP>=110mmHg), heart failure patient (more than NYHA classification III or EF<=35%), severe renal damage patient (serum creatinine level >2 mg/dL), impaired liver function patient (AST or ALT>=100IU/ml), the patient with myocardial infarction, angina, and stroke within six months, an acute gouty attack patient, the patient with renal stone, the patient with taking mercaptopurine hydrate, azathioprine or warfarin, the patient with hypersensitivity to benzbromarone or febuxostat, patients to whom the doctor judged the participation in an examination to be unsuitable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhei Kawano |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Hypertension and Nephrology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Hypertension and Nephrology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan cardiovascular research foundation scientific support enterprise
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2013 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011304
