A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia

Hyperuricemia Clinical Trial

Official title:

A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04180982
• Other study ID #: SHR4640-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 3, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Liu Yi
• Phone: 028-85423237
• Email: hxyyhfb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject has a body mass index =18 and =30 kg/m2;

• Screening sUA value =8mg/dl;

• Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination,imaging examination or safety laboratory values.

Exclusion Criteria:

• Subject known or suspected of being sensitive to the study drugs or its ingredient;

• ALT?AST?TBIL>1.5ULN;

• History of kidney stones or screening kidney stones by B-ultrasound;

• History of malignancy;

• History of xanthinuria;

• Donated blood(=400ml)within 3 months prior to screening or received transfusion of blood.

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• SHR4640 dose1 plus Febuxostat dose1
Tablet,dose1,QD
• SHR4640 dose1 plus Febuxostat dose2
Tablet,dose1, dose2 QD
• SHR4640 dose2 plus Febuxostat dose3
Tablet,dose2, dose3 QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events(AEs) and Serious Adverse Events(SAEs)	Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)	Up to week 4
Secondary	Percentage of subjects with a serum uric level=360µmol/L		At week1, 2, 3 and 4
Secondary	Percentage change from baseline in serum uric level .		At week1, 2, 3 and 4
Secondary	Actual change from baseline in serum uric level		At week1, 2, 3 and 4