CompletedPhase 2

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

China198 participantsStarted 2017-07-20

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Subject who is pregnant or breastfeeding;
✕. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit;
✕. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
✕. HbA1c˃8%;
✕. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
✕. Subject with a history of malignancy;
✕. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen
✕. 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;

Proportion of subjects with a serum uric level≤360μmol/l.

Timeframe: Week 5

NCT IDNCT03185793

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-20