CompletedPhase 3
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
Key facts
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 779 people enrolled
- Started
- 15 Jun 2021
- Ended
- 23 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SHR4640
- Allopurinol
- Record updated
- 24 January 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Subject who has acute gout flares within 2 weeks before randomization
- Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640
- 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
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit
- HbA1c≥8%
- Subject who is pregnant or breastfeeding
- Subject with a positive test for HLA-B*5801
- Estimated glomerular filtration rate (MDRD formula) <60ml/min
- Subject with kidney stones or suspicion of kidney stones
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
The 2 groups in the trial
- Treatment group ATreatment being tested
SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks
Treatment: SHR4640
- Treatment group BExisting treatment, for comparison
Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.
Treatment: Allopurinol
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 24 January 2025