CTRI/2018/10/016116尚未招募4 期
An Open, Prospective, Non-comparative, Multicenter, Post Marketing Surveillance Study to evaluate the Safety and Tolerability of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with chronic Hyperuricemia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 383
- 试验地点
- 22
- 主要终点
- To evaluate the Safety of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.
研究概览
简要总结
An Open, Prospective, Non-comparative, Multicenter, Post MarketingSurveillance Study to evaluate the Safety and Tolerability of Feburic(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with chronicHyperuricemia.
PrimaryObjective: To evaluate the Safety of Feburic (Febuxostat)Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.
SecondaryObjective: To evaluate the Tolerability of Feburic(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with ChronicHyperuricemia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects of age between 18 to 65 years (both inclusive.)
- •Subjects with history of Gout as defined by ACR criteria.
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subjects with suspected hypersensitivity to the study medication or any of the ingredients of the formulation.
- •Subjects with serum uric acid levels >15 mg/dl.
- •Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
- •Subjects with abnormal eGFR (<30 mL/min/1.73 m2) will be excluded from the study.
- •Subjects with known case of Type 1 Diabetes will be excluded from the study.
- •Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study.
- •Subjects with history of uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) within the past 6 months.
- •Subjects with known case of infection with hepatitis B, hepatitis C or HIV.
- •Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias will be excluded from the study.
- •Subjects with known case of Stroke will be excluded from the study.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Subjects currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
To evaluate the Safety of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.
时间窗: At the end of 28 weeks
次要结局
- To evaluate the Tolerability of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia(At the end of 28 weeks)
研究者
研究点 (22)
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