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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025427
Receipt No. R000029269
Scientific Title Study on efficacy and safety of combination treatment with febuxostat and inosine for patients with heart failure
Date of disclosure of the study information 2017/02/26
Last modified on 2017/05/09

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Basic information
Public title Study on efficacy and safety of combination treatment with febuxostat and inosine for patients with heart failure
Acronym Effect of febuxostat and inosine on heart failure
Scientific Title Study on efficacy and safety of combination treatment with febuxostat and inosine for patients with heart failure
Scientific Title:Acronym Effect of febuxostat and inosine on heart failure
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine efficacy and safety of simultaneous administration of febuxostat and inosine for patients with heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of serum BNP between before and after the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Administration of febuxostat 20 mg and inosine 500 mg twice a day for 14 days
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with 20 to 80 years of age
2. Patients with mild or moderate heart failure
3. Those who have the capacity to consent and consented with free will, after sufficient explanation of the purpose and contents of this study, to participate in the study with written document.
4. Patients whose BNP measured within 2 months before the start of the drug administration is higher than the normal range.
Key exclusion criteria 1. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
2. Subjects taking azathioprine or mercaptopurine
3. Subject who has or had renal function disorder.
4. Subject with a history of gout, hyperuricemia or urolithiasis.
5. Patients who changed therapeutic drugs and treatment methods within 1 month before administration of test drugs
6. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Kamatani
Organization Tsukuba International Clinical Pharmacology Clinic
Division name Doctors' office
Zip code
Address 1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL 029-839-1150
Email kamatani@msb.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Suzuki
Organization Tsukuba International Clinical Pharmacology Clinic
Division name Division for Volunteers
Zip code
Address 1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL 029-839-1150
Homepage URL
Email m-suzuki@tsukuba-icp.jp

Sponsor
Institute Tsukuba International Clinical Pharmacology Clinic
Institute
Department

Funding Source
Organization StaGen Co. LTD
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 26 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 Completed
Date of protocol fixation
2016 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 09 Day
Last follow-up date
2017 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029269

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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