A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

Jiangsu HengRui Medicine Co., Ltd.779 enrolled

Overview

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

779

Conditions

Gout

Interventions

SHR4640DRUG

SHR4640 Dose 1 ,tablets, QD

AllopurinolDRUG

Allopurinol 300mg, tablets, QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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: 1. Subject who is pregnant or breastfeeding; 2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; 3. Subject with a positive test for HLA-B\*5801; 4. Estimated glomerular filtration rate (MDRD formula) \<60ml/min; 5. HbA1c≥8%; 6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640; 7. Subject with kidney stones or suspicion of kidney stones; 8. Subject who has acute gout flares within 2 weeks before randomization; 9. Subject with a history of malignancy within the previous 5 years; 10. Subject with a history of active peptic ulcer within a year; 11. Subject with a history of xanthine urine.

Locations (1)

RenJi Hospital, Shanghai JiaoTong University School Of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Proportion of subjects with a serum uric acid level≤360 μmol/L

Time frame: Start of Treatment to end of study (approximately 16 weeks)

Secondary Outcomes

Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment

Time frame: 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

Time frame: 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

Time frame: Start of Treatment to end of study (approximately 16 weeks)

Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment

Time frame: Start of Treatment to end of study (approximately 52 weeks)

change value of serum uric acid from baseline at each visit within 52 weeks of treatment

Time frame: Start of Treatment to end of study (approximately 52 weeks)

proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment

Time frame: Start of Treatment to end of study (approximately 52 weeks)

serum uric acid value at each visit within 52 weeks of treatment

Time frame: Start of Treatment to end of study (approximately 52 weeks)

Data from ClinicalTrials.gov

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