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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012342
Receipt No. R000014392
Scientific Title the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease
Date of disclosure of the study information 2013/11/19
Last modified on 2014/08/14

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Basic information
Public title the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease
Acronym the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease
Scientific Title the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease
Scientific Title:Acronym the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease
Region
Japan

Condition
Condition hyperuricemia and ischemic heart disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To asess the effect of febuxostat on vascular endothelial function,oxidative stress marker,exercise capacity,cardiac function in subjects with hyperuricemia and ischemic heart disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The amount of change of the RH-PAT index
Key secondary outcomes 1.the amount of change of serum uric acid value
2.achievement quotient of serum uric acid level under 6.0mg/dl
3.the amount of change of eGFR
4.the amount of change of BNP level
5.the amount of change of the level of maker of inflammation
6.the amount of change of the level of maker of oxidative stress
7.cadiac function indexes on echocardiography
8.change in exercise capacity indexes
9.simptom of angina pectoris
10.the amount of change of fasting blood glucose level and HbA1c

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lifestyle adjustment
Interventions/Control_2 febuxostat administration
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 subjects must match all conditions below.
1.patients with serum uric acid level over 7.0mg/dl.
2.patients with ischemic heart disease.
3.patients older than 20 years old.
4.patients agreed with consent form.
Key exclusion criteria 1.patients with a history of hypersensitivity to febuxostat.
2.patients with AST or ALT level over than the twice the facilitie standard value.
3.patients with severe renal dysfunction(eGFR under 15 mL/min./1.73m2 or hemodialysis patients).
4.patients received the uric acid descent medicine within two weeks before competent judgment.
5.patients within 1weeks from onset of acute myocardial infarction.
6.patients underwent CABG and after radial artery graft excision.
7. patients with malignant tumor or past history of malignant tumor (except patients with no recurrence or who didn't need specialized treatment for malignant tumor within 5 recent years).
8.patients who take mercaptopurine hydrate
,azathioprine,pyrazinamide or ethambutol.
9.patients participated to other clinical trials within recent 6 months.
10.patients judged not to be suitable as a subject by attending doctor. Especially, patients with serum uric acid level over 9mg/dl should be considered about not to participate to this trial.
Target sample size 62

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Ishihara
Organization National Cerebral and Cardiovascular Center.
Division name Division of Cardiology
Zip code
Address 5-7-1,Fujishirodai,Suita city,Osaka,Japan
TEL 06-6833-5012
Email ishihara.masaharu.hp@mail.ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Fujiwara
Organization National Cerebral and Cardiovascular Center.
Division name Division of Cardiology
Zip code
Address 5-7-1,Fujishirodai,Suita city,Osaka,Japan
TEL 06-6833-5012
Homepage URL
Email reikofuj@hsp.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center.
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 国立循環器病研究センター

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 19 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
2013 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 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 11 Month 19 Day
Last modified on
2014 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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