A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
Study Details
Study Description
Brief Summary
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment group A SHR4640+Allopurinol Placebo;once a day, orally, for 16 weeks |
Drug: SHR4640
SHR4640 Dose 1 ,tablets, QD
|
Active Comparator: Treatment group B Allopurinol+ SHR4640 Placebo;once a day, orally, for 16 weeks. |
Drug: Allopurinol
Allopurinol 300mg, tablets, QD
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with a serum uric acid level≤360 μmol/L [Start of Treatment to end of study (approximately 16 weeks)]
Secondary Outcome Measures
- Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment [Start of Treatment to end of study (approximately 16 weeks)]
- Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment [Start of Treatment to end of study (approximately 16 weeks)]
- The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment [Start of Treatment to end of study (approximately 16 weeks)]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.
Exclusion Criteria:
-
Subject who is pregnant or breastfeeding;
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Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
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Subject with a positive test for HLA-B*5801;
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Estimated glomerular filtration rate (MDRD formula) <60ml/min;
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HbA1c≥8%;
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Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;
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Subject with kidney stones or suspicion of kidney stones;
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Subject who has acute gout flares within 2 weeks before randomization;
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Subject with a history of malignancy within the previous 5 years;
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Subject with a history of active peptic ulcer within a year;
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Subject with a history of xanthine urine.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | RenJi Hospital, Shanghai JiaoTong University School Of Medicine | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR4640-303