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

Overview

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

Full Title of Study: “Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 20, 2018

Interventions

  • Drug: Placebo
    • Placebo once daily for 5 weeks
  • Drug: SHR4640
    • 1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
  • Drug: benzbromarone
    • 25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • placebo for 5 weeks
  • Experimental: 2.5mg SHR4640
    • SHR4640 for 5 weeks
  • Experimental: 5mg SHR4640
    • SHR4640 for 5 weeks
  • Experimental: 10mg SHR4640
    • SHR4640 for 5 weeks
  • Active Comparator: 50mg benzbromarone
    • Benzbromarone for 5 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects with a serum uric level≤360μmol/l.
    • Time Frame: Week 5

Secondary Measures

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

Participating in This Clinical Trial

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.

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chunde Bao, Principal Investigator, shanghai Jiaotong University, School of Medicine, Renji Hospital

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