CTIS2022-501421-20-00招募中1 期
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 - LG-GDCL010
G Chem Ltd.0 个研究点目标入组 5,052 人开始时间: 2023年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,052
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject or the subject’s legally acceptable representative is willing and able to provide written ICF prior to the initiation of any study procedures., Male or female subjects between the ages of 18 and 85 years, inclusive., Subjects with hyperuricemia and a history or presence of gout per ACR/EULAR 2015 criteria (Neogi et al 2015)., Subjects who are currently on 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 a sUA level =7.0 mg/dL at Visit 3 to be randomized and participate in the study., Subjects with a BMI =50 kg/m2 at screening (Visit 1)., Subjects with eGFR =30 mL/min/1.73m2 at screening (Visit 1).
排除标准
- •Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder or their treatment, organ transplant, therapeutic regimens that produce hyperuricemia, renal failure, renal tubular disorders, lead poisoning, hyperproliferative skin disorders, enzymatic defects (eg, deficient hypoxanthine-guanine phosphoribosyl transferase, glycogen storage diseases))., Subjects experiencing an active acute gout attack within 2 weeks prior to screening (Visit 1)., Subjects who are Asian descent (eg, Han Chinese, Korean, Thai) and Black/African descent (eg. African American) with a positive test for HLA B*58:01., Subjects who have received uricase (e.g., pegloticase)., Subjects who have not been receiving stable doses of drugs known to affect sUA levels (losartan, fibrates, thiazide diuretics, loop diuretics, ASA) for the last 3 weeks prior to screening (Visit 1). Acetylsalicylic acid use more than 325 mg/day is not allowed., Subjects with a history of xanthinuria.
研究者
相似试验
Unknown
3 期
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314CTRI/2021/12/038691Chong Kun Dang Pharmaceutical Corp46
终止
不适用
A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19KCT0006614Chong Kun Dang586
进行中（未招募）
不适用
Clinical study comparing a new signle dose chewable tablet as treatment knee osteoarthritis with moderate to severe pain, compared to Placebo and CelecoxibKnee osteoarthritis with moderate to severe pain.MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-005398-22-ESARAFARMA GROUP, S.A.
已完成
3 期
To Evaluate the Efficacy and Safety of Etifoxine in Comparison to Alprazolam for the Treatment of Adult Patients with Generalized Anxiety Disorder (a condition of excessive worry about everyday situations) with Somatic Symptoms (an extreme focus on physical symptoms such as pain or fatigue)CTRI/2023/01/048875Sun Pharma Laboratories Limited (SPLL)260
尚未招募
3 期
A clinical study to see the effect and safety of Fixed Dose Combination of Silodosin and Solifenacin Capsules in Comparison to Silodosin Capsules in Male Patients Having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) with Over Active Bladder (OAB)CTRI/2020/07/026419Sun Pharma Laboratories Limited