UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023905 |
|---|---|
| Receipt number | 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 11:28:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kojimas@kumamoto-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027528
