JPRN-jRCT2080222512未知2 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase 2 Study to Evaluate Efficacy and Safety of RDEA3170 5mg, 7.5mg, 10mg, 12.5mg and 15mg Versus Placebo and Open-Label Allopurinol 200mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia
适应症
试验速览
- 阶段
- 2 期
- 发起方
- AstraZeneca
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
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Subject meets any of the following criteria and with sUA 10.0 mg/dL or more:
- •a. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
- •b. sUA level of 8.0 mg/dL or more at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
- •c. sUA level of 9.0 mg/dL or more at 7 days prior to baseline without gout and complications.
排除标准
- •- Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
- •- Subject has a history or suspicion of kidney stones.
- •- Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula
- •- Subject is receiving strong or moderate CYP3A inhibitors
研究者
相似试验
进行中（未招募）
1 期
A placebo-Controlled,Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Patients with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for RevascularizatioEUCTR2015-005532-18-CZPluristem Ltd.246
进行中（未招募）
1 期
A placebo-Controlled,Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Patients with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for RevascularizatioEUCTR2015-005532-18-DEPluristem Ltd.300
进行中（未招募）
1 期
BCX9930 compared to placebo in the treatment of PNHEUCTR2020-004403-14-ITBIOCRYST PHARMACEUTICALS INC.57
进行中（未招募）
1 期
A Clinical Study to test the effect of the drug Itraconazole (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary AspergillosisAsthma with Allergic Bronchopulmonary AspergillosisMedDRA version: 20.1Level: PTClassification code 10006474Term: Bronchopulmonary aspergillosis allergicSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-002949-11-GBPulmatrix, Inc.64
进行中（未招募）
1 期
BCX9930 compared to placebo in the treatment of PNHParoxysmal Nocturnal HemoglobinuriaMedDRA version: 21.1Level: PTClassification code 10034042Term: Paroxysmal nocturnal haemoglobinuriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2020-004403-14-ESBioCryst Pharmaceuticals Inc57