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Long-term safety of urate-lowering drugs and their protective effects on important organs

Long-term safety of urate-lowering drugs and their protective effects on important organs

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035778
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout/Hyperuricemia

Interventions

Allopurinol Group:Allopurinol is recommended to start at 100mg and 50mg for patients with renal insufficiency
Febuxostat Group:Febuxostat start at 20mg
Benzbromarone Group:Benzbromarone start at 25mg

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old, male or female; 2. Patients with hyperuricemia and a history of gout attack and blood uric acid level > 8.0mg/dl (480umol/l); 3. Volunteer and sign informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe renal function impairment (eGFR < 30ml/min*1.73m2) (2009EP formula); 2. Patients with ALT or AST more than 2 times of the upper limit of normal (patients with abnormal liver function, but whose ALT or AST not exceed 3 times of the upper limit of normal, and can be explained by fatty liver can include into the study); 3. Women who are breast-feeding or pregnant, and those who plan to get pregnant, not willing to or havent take sufficient contraceptive measures during the period of childbearing age; 4. Have a history of allergy to any ingredient of uric acid lowering drugs; 5. Patients receiving azathiopurine or mercaptopurine therapy; 6. Inability or unwillingness to offer informed consent or to comply with the trial requirements; 7. Other factors researchers consider not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Major Adverse Cardiovascular Events;Chinese cardiovascular and cerebrovascular assessment;

Secondary

MeasureTime frame
Acute gout attack;eGFR;Liver fuction;Blood pressure;Blood routine;

Countries

China

Contacts

Public ContactZou Hejian

Huashan Hospital, Fudan University

hjzou@unirheuma.org+86 13311881366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026