Completed
A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat
What is being tested
lesinurad
+ febuxostat
+ lesinurad
Drug
Who is being recruted
Crystal Arthropathies+9
+ Arthritis
+ Joint Diseases
From 18 to 85 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: March 2013
Summary
Principal SponsorArdea Biosciences, Inc.
Last updated: January 30, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Principal SponsorArdea Biosciences, Inc.
Last updated: January 30, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
196 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Crystal ArthropathiesArthritisJoint DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsRheumatic DiseasesGenetic Diseases, InbornGout
Criteria
3 inclusion criteria required to participate
Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit
Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity
Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication
1 exclusion criteria prevent from participating
Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Group II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 72 locations
Birmingham, United StatesOpen in Google Maps
Tempe, United States
Glendale, United States
Huntington Beach, United States
Completed72 Study Centers