Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: SHR4640; Drug: benzbromarone; Drug: Placebo

• Registration Number: NCT03185793
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2017-07-20
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

1. 18-70 years, male or female;
2. Subject meets one of the following conditions:

1. Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.

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Exclusion Criteria

1. Subject who is pregnant or breastfeeding;
2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
3. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
4. HbA1c˃8%;
5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
6. Subject with a history of malignancy;
7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen
8. Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;
9. Subject has acute gout flares within 2 weeks before randomization;
10. Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;
11. Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;
12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.5mg SHR4640	SHR4640	SHR4640 for 5 weeks
10mg SHR4640	SHR4640	SHR4640 for 5 weeks
50mg benzbromarone	benzbromarone	Benzbromarone for 5 weeks
5mg SHR4640	SHR4640	SHR4640 for 5 weeks
Placebo	Placebo	placebo for 5 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a serum uric level≤360μmol/l.	Week 5

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a serum uric level≤360μmol/l	At week1, 2, 3 and 4
Incidence of gout flares requiring treatment.	Up to week 5
Rate of gout flares requiring treatment.	Up to week 5
Actual change from baseline in serum uric level	At week 1, 2, 3 and 4
Percentage change from baseline in serum uric level	At week 1, 2, 3 and 4
Proportion of subjects with a serum uric level consistent ≤360μmol/l	At week 3, 4 and 5
Actual change from baseline in serum uric level.	Week 5
Percentage change from baseline in serum uric level .	Week 5

Trial Locations

Locations (1)

Jiangsu Hengrui Medicine Co., Ltd.; 🇨🇳 Shanghai, Shanghai, China