UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009817
Receipt number R000011503
Scientific Title Randomized controlled trial of febuxostat and allopurinol on chronic heart failure patients with hyperuricemia
Date of disclosure of the study information 2013/01/20
Last modified on 2019/08/01 11:57:34

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Basic information

Public title

Randomized controlled trial of febuxostat and allopurinol on chronic heart failure patients with hyperuricemia

Acronym

Comparison of the effect of hyperuricemic drug on chronic heart failure patients

Scientific Title

Randomized controlled trial of febuxostat and allopurinol on chronic heart failure patients with hyperuricemia

Scientific Title:Acronym

Comparison of the effect of hyperuricemic drug on chronic heart failure patients

Region

Japan


Condition

Condition

Chronic heart failure with hyperuricemia

Classification by specialty

Medicine in general Cardiology Nephrology
Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to compare the relation of anti-oxidative stress effect and prognostic improvement of choronic heart failure patients between febuxostat and allopurinol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cardiac death and rehospitalization due to worsening heart failure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Febuxostat:250
Period: 2012.12-2016.3

Interventions/Control_2

allopurinol:250
Period: 2012.12-2016.3

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Chronic heart failure patients with hyperuricemia
2.Stable outpatients (NYHA I-III)

Key exclusion criteria

1.Acute heart failure patients or acute myocardial infarction patients
2.Patients with renal failure (over Cr 2.0 mg/dl)
3.Patients who had already anti-hyperuricemic drug
4.Patietns with hypersensitivity of study drug
5.Pregnant woman

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yasuchika
Middle name
Last name Yasuchika

Organization

Fukushima Medical University

Division name

Deaprtment of Cardiovascular Medicine

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima

TEL

024-547-1190

Email

takeishi@fmu.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Suzuki

Organization

Fukushima Medical University

Division name

Department of Cardiovascular Medicine

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima

TEL

024-547-1190

Homepage URL


Email

ssatoshi@fmu.ac.jp


Sponsor or person

Institute

Deaprtment of Cardiovascular Medicine, Fukushima Medical University.

Institute

Department

Personal name



Funding Source

Organization

Japan Heart Foundation

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

Clinical Reserch Center, Fukushima Medical University

Address

1 Hikarigaoka, Fukushima

Tel

024-547-1772

Email

ssatoshi@fmu.ac.jp


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 01 Month 20 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

263

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

Completed

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB

2012 Year 05 Month 28 Day

Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 01 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 20 Day

Last modified on

2019 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name