UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Sunao Kojima
Organization	Kumamoto University
Division name	Cardiovascular medicine
Address	1-1-1 Honjo, Chuo-ku Kumamoto
TEL	096-373-5175
Email	kojimas@kumamoto-u.ac.jp

Public contact
Name of contact person	Sunao Kojima
Organization	Kumamoto University
Division name	Cardiovascular medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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