Beneficial effect by Xanthine oxidase inhibitor on endothelial function beyond Uric Acid trial

JRCT ID: jRCTs031180406

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hyperuricemia complicated with hypertension
• Date of first enrollment: 27/03/2018
• Target sample size: 140
• Study type: Interventional

Intervention(s)

The Topiroxostat treatment group is administrated 40mg/day of Topiroxostat at the beginning of treatment period and then titrated up to 160mg/day to maintain serum uric acid levels less than 6 mg/dl.
The Febuxostat treatment group is administrated 10mg/day of Topiroxostat at the beginning of treatment period and then titrated up to 60mg/day to maintain serum uric acid levels less than 6 mg/dl.

Outcome(s)

• Primary Outcome: Changes in CAVI from baseline to 24 weeks

Secondary Outcome

The change or percent change for the following items from baseline to 24 weeks or 12 weeks.
1.Cardio Ankle Vascular Index
2.PWV, ABI, pulse wave of the extremities
3.Serum uric acid
4.Continuous blood pressure monitoring (5days)
5.Clinic blood pressure
6.hs-CRP
7.NT-proBNP
8.hs-TnT
9.Urinary L-FABP
10.Urine Albumin-to-Creatinine Ratio
11.CysC
12.8-OHdG

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study.
1. Age =>30 and <80 at the time of giving their consent
2. Patients with gout or Hyperuricemia who are untreated or treated with Allopurinol (Serum uric acid > 7.0mg/dL)
3. Hypertensive patients receiving stable antihypertensive treatment at least 3 months at study enrollment
4. 8=<CAVI=<12 at enrollment
5. Written informed consent by his/her own will

Exclude criteria

Patients who meet any of the following criteria are not eligible for the study
1.History of hypersensitivity to Topiroxostat, Febuxostat or Allopurinol
2.Treated with the following hyperuricemic drugs within 4 weeks before the enrollment: Topiroxostat, Febuxostat, Benzbromarone, Probenecid, Bucolome
3.Under treatment with the following drugs at the enrollment; Probenecid, Bucolome, Benzbromarone, Mercaptopurine or Azathioprine
4.Cancer patients (excluding those completely cured)
5.Patients with gouty arthritis within 2 weeks before enrollment
6.Patients who have high AST or ALT as twice as the upper limit of hospital's reference value
7.Patients with serious liver dysfunction (Child Pugh B, C)
8.Patient with renal dysfunction (eGFR <30ml/min/1.73m2)
9.Patients with severe heart failure (CHF, NYHA functional class 3 and 4)
10.History of acute coronary syndrome or stroke within 3 months
11.Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility (excludes observational studies)
12.Patients who are considered to be inappropriate for the participation in this study by the investigators

Related Information

• Primary Sponsor: Kario Kazuomi
• Source(s) of Monetary Support: Sanwa Kagaku Kenkyusho Co., Ltd.
• Secondary ID(s): UMIN000031096