Status:
COMPLETED
A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Gout
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout
Eligibility Criteria
Inclusion
- Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening;
- 18 kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2
Exclusion
- Subject who is pregnant or breastfeeding;
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit;
- Subject with a positive test for HLA-B\*5801;
- Estimated glomerular filtration rate (MDRD formula) \<60ml/min;
- HbA1c\>8%;
- Subject with known hypersensitivity or allergy to SHR4640 and allopurinal, or any component of SHR4640;
- Subject with kidney stones or suspicion of kidney stones;
- Subject who has acute gout flares within 2 weeks before randomization;
- Subject with a history of malignancy within the previous 5 years;
- Subject with a history of active peptic ulcer within a year;
- Subject with a history of xanthine urine.
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2021
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT04052932
Start Date
July 16 2019
End Date
July 14 2021
Last Update
June 13 2022
Active Locations (1)
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1
RenJi Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000