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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023905
Receipt No. R000027528
Scientific Title Therapeutic Strategy for Efficient Reduction of Serum Uric Acid Levels with Allopurinol versus Benzbromarone in Hyperuricemic Patients with Essential Hypertension-A Randomized Crossover Study (TERAO study)
Date of disclosure of the study information 2016/09/02
Last modified on 2016/09/02

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Basic information
Public title Therapeutic Strategy for Efficient Reduction of Serum Uric Acid Levels with Allopurinol versus Benzbromarone in Hyperuricemic Patients with Essential Hypertension-A Randomized Crossover Study (TERAO study)
Acronym TERAO study
Scientific Title Therapeutic Strategy for Efficient Reduction of Serum Uric Acid Levels with Allopurinol versus Benzbromarone in Hyperuricemic Patients with Essential Hypertension-A Randomized Crossover Study (TERAO study)
Scientific Title:Acronym TERAO study
Region
Japan

Condition
Condition hyperuricemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of different drugs used to treat hyperuricemia on cardiovascular risk factors, we designed a crossover study employing both a urate transporter-1 inhibitor (benzbromarone) and xanthine oxidase inhibitor (allopurinol).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the change of serum and urine urate and proteinuria
Key secondary outcomes none

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We randomized 7 consecutive patients with microalbuminuria having hypertension (>140/90 mm Hg or taking anti-hypertensive medications) and hyperuricemia (serum uric acid levels >7 mg/dL) to receive either benzbromarone 25 mg once daily for the first four weeks of the study.
Interventions/Control_2 We randomized 7 consecutive patients with microalbuminuria having hypertension (>140/90 mm Hg or taking anti-hypertensive medications) and hyperuricemia (serum uric acid levels >7 mg/dL) to receive allopurinol 200 mg twice daily for the first four weeks of the study.
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 patients having hypertension (>140/90 mm Hg or taking anti-hypertensive medications) and hyperuricemia (serum uric acid levels >7 mg/dL).
Key exclusion criteria patients in whom informed consent could not be received.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sunao Kojima
Organization Kumamoto University
Division name Cardiovascular medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku Kumamoto
TEL 096-373-5175
Email kojimas@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sunao Kojima
Organization Kumamoto University
Division name Cardiovascular medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku Kumamoto
TEL 096-373-5175
Homepage URL
Email kojimas@kumamoto-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Kumamoto University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Terao Hospital
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 熊本大学医学部附属病院
寺尾病院

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 02 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
2013 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 12 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 06 Month 30 Day
Date analysis concluded
2016 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2016 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027528

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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