JPRN-jRCT2031220036招募中2 期
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase II Study)
Masahiko Fushimi0 个研究点目标入组 30 人开始时间: 2022年4月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- >= 6age old 至 <= 18age old（—）
- 性别
- All
入选标准
- •Hyperuricemic pediatric patients with or without gout
- •-Serum urate level:
- •>= 7.0 mg/dL in patients with history of gout, or
- •>= 8.0 mg/dL in patients complicated with kidney disease, hypertension, diabetes, metabolic syndrome or ischemic heart disease, or
- •>= 9.0 mg/dL in patients with not applicable the above
排除标准
- •-Gouty arthritis within two weeks before start of study treatment
- •-Renal overload type of hyperuricemia
- •-HbA1c: >= 9.0%
- •-Clinically significant cardiac, and hepatic disease
- •-Kidney calculi or clinically significant urinary calculi
- •-eGFR: < 30 mL/min/1.73 m^2
- •-AST: >3xULN (upper limit of normal) or ALT: >3xULN
- •-Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
研究者
相似试验
尚未招募
不适用
Alternative treatment to treatment nonresponsive leprosyCTRI/2022/09/045483Prof Nusrat Shafiq
招募中
不适用
A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of sunitinibrenal cell carcinomaJPRN-UMIN000015553Department of Pharmacy, Gifu University Hospital50
已完成
不适用
A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinibadenocarcinoma of the lungJPRN-UMIN000014237aboratoly of Pharmacy Practice and Social Science, Gifu Pharmaceutical University43
已完成
不适用
A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patientsPulmonary arterial hypertensionJPRN-UMIN000010355Department of clinical pharmacology and genetics, school of pharmaceutical science, university of Shizuoka graduate school100
未知
不适用
A-L03-L088 Other specified local infections of skin and subcutaneous tissue-L02Other specified local infections of skin and subcutaneous tissueL02L03L088PER-006-13Cubist Pharmaceuticals, Inc,