Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
A legfontosabb adatok
- Hol
- Albuquerque, Aventura, Babylon, Banning, Baytown, Birmingham, Boise, Bountiful, Buena Park, Chandler, Charlotte, Chicago, Clearwater, Colleyville, Columbus, Coral Gables, Covington, Cutler Bay, Dallas, Daphne, DeBary, Evansville, Fargo, Flagstaff, Flossmoor, Fort Myers, Fort Worth, Franklin, Fremont, Gainesville, Glendale, Greensboro, Gurnee, Hatboro, Hazelwood, Hendersonville, Hialeah, Honolulu, Houston, Jackson, Kansas City, Knoxville, Lake Mary, Lakewood, Las Vegas, Lexington, Little Rock, Meridian, Mesa, Mesquite, Metairie, Miami, Minot, Missoula, Mobile, Morganton, Muncie, Muscle Shoals, New York, Newnan, Norfolk, Olive Branch, Orlando, Oxon Hill, Perrysburg, Philadelphia, Phoenix, Plano, Port Gibson, Portsmouth, Rancho Cucamonga, Richmond, Salt Lake City, San Antonio, San Diego, Santa Fe, Shawnee Mission, Sheffield, Shelby, South Ogden, Spokane, St Louis, St. Petersburg, Sugar Land, Tampa, Tempe, Tomball, Vandalia, Versailles, Vestal, West Des Moines, West Jordan, Wichita és Winter Park (Egyesült Államok)Mind a 123 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Albuquerque Center for RheumatologyAlbuquerque, Egyesült ÁllamokNo longer taking part
- Arthritis & Rheumatic Disease SpecialtiesAventura, Egyesült ÁllamokNo longer taking part
- Long Island Regional Arthritis & Osteoporosis Care PCBabylon, Egyesült ÁllamokNo longer taking part
- Velocity Clinical ResearchBanning, Egyesült ÁllamokNo longer taking part
- Inquest Clinical ResearchBaytown, Egyesült ÁllamokNo longer taking part
- University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
- Family Care Research, LLCBoise, Egyesült ÁllamokNo longer taking part
- Cope Family Medicine/CCT ResearchBountiful, Egyesült ÁllamokNo longer taking part
- American Clinical TrialsBuena Park, Egyesült ÁllamokNo longer taking part
- Arizona Research Clinic PLLCChandler, Egyesült ÁllamokNo longer taking part
- Presbyterian HospitalCharlotte, Egyesült ÁllamokNo longer taking part
- Great Lakes Clinical TrialsChicago, Egyesült ÁllamokNo longer taking part
- IMA Research, Inc.Chicago, Egyesült ÁllamokNo longer taking part
- Clinical Research of West Florida, Inc.Clearwater, Egyesült ÁllamokNo longer taking part
- PCCR SolutionsColleyville, Egyesült ÁllamokNo longer taking part
- Centricity ResearchColumbus, Egyesült ÁllamokNo longer taking part
- Herco Medical and Research Center, IncCoral Gables, Egyesült ÁllamokNo longer taking part
- Clinical Trials Management, LLCCovington, Egyesült ÁllamokNo longer taking part
- Nouvelle Clinical Research LLCCutler Bay, Egyesült ÁllamokNo longer taking part
- DFW Clinical ResearchDallas, Egyesült ÁllamokNo longer taking part
- Metroplex Clinical Research CenterDallas, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCDaphne, Egyesült ÁllamokNo longer taking part
- Omega Research Debary, LLCDeBary, Egyesült ÁllamokNo longer taking part
- MediSphere Medical Research Center, LLCEvansville, Egyesült ÁllamokNo longer taking part
- Lillestol Research, LLCFargo, Egyesült ÁllamokNo longer taking part
- Arizona Arthritis & Rheumatology Associates P.C.Flagstaff, Egyesült ÁllamokNo longer taking part
- Healthcare Research Network II, LLCFlossmoor, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCFort Myers, Egyesült ÁllamokNo longer taking part
- Dallas Fort Worth Clinical Research AssociatesFort Worth, Egyesült ÁllamokNo longer taking part
- American Health Network of Indiana, LLCFranklin, Egyesült ÁllamokNo longer taking part
- Methodist Physicians Clinic / CCT ResearchFremont, Egyesült ÁllamokNo longer taking part
- Arthritis Center of North GeorgiaGainesville, Egyesült ÁllamokNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCGlendale, Egyesült ÁllamokNo longer taking part
- Triad Clinical Trials, LLCGreensboro, Egyesült ÁllamokNo longer taking part
- Clinical Investigation Specialists, Inc.Gurnee, Egyesült ÁllamokNo longer taking part
- Hatboro Medical Associates, P.C.Hatboro, Egyesült ÁllamokNo longer taking part
- Healthcare Research NetworkHazelwood, Egyesült ÁllamokNo longer taking part
- Olympus Family MedicineHendersonville, Egyesült ÁllamokNo longer taking part
- Best Quality Research, IncHialeah, Egyesült ÁllamokNo longer taking part
- Direct Helpers Research CenterHialeah, Egyesült ÁllamokNo longer taking part
- New Generation of Medical Research, LLC.Hialeah, Egyesült ÁllamokNo longer taking part
- Vital Pharma ResearchHialeah, Egyesült ÁllamokNo longer taking part
- East-West Medical Research InstituteHonolulu, Egyesült ÁllamokNo longer taking part
- Pioneer Research Solutions, Inc.Houston, Egyesült ÁllamokNo longer taking part
- Elite Clinical Research LLCJackson, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCKansas City, Egyesült ÁllamokNo longer taking part
- Clay-Platte Family Medicine ClinicKansas City, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCKnoxville, Egyesült ÁllamokNo longer taking part
- New Phase ResearchKnoxville, Egyesült ÁllamokNo longer taking part
- Accel Research Sites - LakelandLake Mary, Egyesült ÁllamokNo longer taking part
- Accel Research Sites - St. Petersburg- LargoLake Mary, Egyesült ÁllamokNo longer taking part
- ARS-Matiland Clinical Research UnitLake Mary, Egyesült ÁllamokNo longer taking part
- Shreenath Clinical ServiceLakewood, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCLas Vegas, Egyesült ÁllamokNo longer taking part
- Healor Primary Care / CCT ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
- Wake Research - CRCNLas Vegas, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCLexington, Egyesült ÁllamokNo longer taking part
- Lynn Institute of the OzarksLittle Rock, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCMeridian, Egyesült ÁllamokNo longer taking part
- Arizon Arthritis & Rheumatology Research, PLLCMesa, Egyesült ÁllamokNo longer taking part
- Desert Clinical Research/CCT ResearchMesa, Egyesült ÁllamokNo longer taking part
- SouthWest Rheumatology Research, LLCMesquite, Egyesült ÁllamokNo longer taking part
- Clinical Trials ManagementMetairie, Egyesült ÁllamokNo longer taking part
- Allied Biomedical Research InstituteMiami, Egyesült ÁllamokNo longer taking part
- Care Research Center IncMiami, Egyesült ÁllamokNo longer taking part
- Clinical Site Partners LLC, dba Flourish ResearchMiami, Egyesült ÁllamokNo longer taking part
- D&H National Research Centers, IncMiami, Egyesült ÁllamokNo longer taking part
- Homestead Associates in Research Inc.Miami, Egyesült ÁllamokNo longer taking part
- Ivetmar Medical Group, LLCMiami, Egyesült ÁllamokNo longer taking part
- M&A Medical Centers and ResearchMiami, Egyesült ÁllamokNo longer taking part
- Miami Dade Medical Research Institute, LLCMiami, Egyesült ÁllamokNo longer taking part
- Pharmax Research of South Florida, IncMiami, Egyesült ÁllamokNo longer taking part
- Trinity Health Center Medical ArtsMinot, Egyesült ÁllamokNo longer taking part
- Montana Medical Research, IncMissoula, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCMobile, Egyesült ÁllamokNo longer taking part
- Burke Primary CareMorganton, Egyesült ÁllamokNo longer taking part
- American Health Network of Indiana LLCMuncie, Egyesült ÁllamokNo longer taking part
- Syed Research Consultants, LLCMuscle Shoals, Egyesült ÁllamokNo longer taking part
- IMA Clinical ResearchNew York, Egyesült ÁllamokNo longer taking part
- Vista Clinical Research, LLCNewnan, Egyesült ÁllamokNo longer taking part
- Meridian Clinical Research, LLCNorfolk, Egyesült ÁllamokNo longer taking part
- Olive Branch Family Medical CenterOlive Branch, Egyesült ÁllamokNo longer taking part
- HMD Research, LLCOrlando, Egyesült ÁllamokNo longer taking part
- MD Medical ResearchOxon Hill, Egyesült ÁllamokNo longer taking part
- Arthritis Associates of Northwest Ohio Inc.Perrysburg, Egyesült ÁllamokNo longer taking part
- Tristar Clinical Investigations, P.C.Philadelphia, Egyesült ÁllamokNo longer taking part
- Elite Clinical Studies, LLCPhoenix, Egyesült ÁllamokNo longer taking part
- Aim Trials, LLCPlano, Egyesült ÁllamokNo longer taking part
- Practice Dr. David HeadleyPort Gibson, Egyesült ÁllamokNo longer taking part
- Meridian Clinical Research, LLCPortsmouth, Egyesült ÁllamokNo longer taking part
- Rancho Cucamonga Clinical ResearchRancho Cucamonga, Egyesült ÁllamokNo longer taking part
- Dominion Medical Associates, Inc.Richmond, Egyesült ÁllamokNo longer taking part
- Highland Clinical ResearchSalt Lake City, Egyesült ÁllamokNo longer taking part
- Olympus Family MedicineSalt Lake City, Egyesült ÁllamokNo longer taking part
- Clinical Trials of Texas IncSan Antonio, Egyesült ÁllamokNo longer taking part
- Rheumatology Center of San DiegoSan Diego, Egyesült ÁllamokNo longer taking part
- Triwest Research AssociatesSan Diego, Egyesült ÁllamokNo longer taking part
- Inspire Santa Fe Medical GroupSanta Fe, Egyesült ÁllamokNo longer taking part
- Women's & Family Care LLC, dba GTC ResearchShawnee Mission, Egyesült ÁllamokNo longer taking part
- Syed Research Consultants LlcSheffield, Egyesült ÁllamokNo longer taking part
- Carolina Research Center, IncShelby, Egyesült ÁllamokNo longer taking part
- South Ogden Family Medicine ClinicSouth Ogden, Egyesült ÁllamokNo longer taking part
- Arthritis Northwest, PLLCSpokane, Egyesült ÁllamokNo longer taking part
- IMA Clinical ResearchSt Louis, Egyesült ÁllamokNo longer taking part
- St. Louis Medical Professionals, LLCSt Louis, Egyesült ÁllamokNo longer taking part
- IMA Clinical ResearchSt. Petersburg, Egyesült ÁllamokNo longer taking part
- Sugar Lakes Family Practice, PASugar Land, Egyesült ÁllamokNo longer taking part
- Adult Medicine of Lake County, Inc.Tampa, Egyesült ÁllamokNo longer taking part
- Clinical Research of West Florida IncTampa, Egyesült ÁllamokNo longer taking part
- Clinical Research Trials of Florida, Inc.Tampa, Egyesült ÁllamokNo longer taking part
- ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Nodal Medical CenterTampa, Egyesült ÁllamokNo longer taking part
- Research Institute of South Florida, Inc.Tampa, Egyesült ÁllamokNo longer taking part
- Fiel Family and Sports Medicine/CCT ResearchTempe, Egyesült ÁllamokNo longer taking part
- DM Clinical ResearchTomball, Egyesült ÁllamokNo longer taking part
- STAT ResearchVandalia, Egyesült ÁllamokNo longer taking part
- Versailles Family MedicineVersailles, Egyesült ÁllamokNo longer taking part
- Conquest ResearchVestal, Egyesült ÁllamokNo longer taking part
- Integrated Clinical Trial Services, Inc.West Des Moines, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research LLCWichita, Egyesült ÁllamokNo longer taking part
- Clinical Site Partners, LLC DBA CSP OrlandoWinter Park, Egyesült ÁllamokNo longer taking part
- Conquest ResearchWinter Park, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- LG Chem
- Azonosító
- NCT05586971EU 2022-501421-20-00
- A regiszteradat frissítve
- 2025. július 22.
- Eredeti leírás
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.A teljes eredeti leírásKevesebb
A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
Bevonási feltételek: Male or female subjects between the ages of 18 85 years, inclusive; Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria; Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study; Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
Kizáró feltételek: Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1); Subjects who have received pegloticase to treat gout which has not responded to the usual treatments; Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1); Subjects with a history of xanthinuria (elevated levels of xanthine in the urine); Subjects with secondary hyperuricemia and enzymatic defects.