KCT0000927招募中未知
A multicenter, randomized, double blind, double dummy, 16-week, Parallel, Placebo controlled study to evaluate the efficacy and safety of Probucol in patients with nephropathy due to type 2 diabetes.
Korea Otsuka Pharmaceuticals0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1)Outpatients with type 2 diabetes (duration of illness more than 5 years) at age of 20 to 80 years at the time of screening visit
- •2)Patients with overt albuminuria at the time of screening visit
- •-A/C Ratio = 300mg/g Cr
- •3)Subjects administered with ACEI and/or ARB without changing dosage for more than 3 months prior to the screening visit
- •4)Subjects administered with statins without changing dosage for more than 3 months prior to the screening visit or subjects who are currently not administering statins and have no plan to administer statins during the clinical trial
- •5)Subjects with eGFR above 15 mL/min and under 90 mL/min at the time of screening visit
- •6)Subjects who agreed to participate in this clinical trial with written ICF prior to the screening visit
排除标准
- •1)Type 1 DM or gestational diabetes
- •2)Subjects having experience of dialysis or kidney transplantation prior to screening visit
- •3)Subjects with ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
- •4)Cardiac damage (subjects showing abnormal levels of Troponin I)
- •5)Subjects with medical history of cardiac syncope or primary syncope
- •6)Subjects having abnormally prolonged QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec).
- •7)Pregnant or lactating woman before screening or registration
- •8)Subjects with inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- •9)Intra,external hepatic cholestatsis
- •10)Congestive heart failure
- •11)Subjects with myocardial infarction or cerebral infarction within the latest 6 months since the screening
- •12)Subjects with heart failure diagnosed of NYHA grade III-IV status who is under treatment or needs treatment
- •13)AST or ALT is 3 times higher than the upper limit of the normal range at the screening visit
- •14)Active hepatitis or liver cirrhosis
- •15)Subjects with Hyperkalemia (serum potassium concentration exceeding 5.5 mEq/L)
- •16)Subjects with renal artery stenosis
- •17)Subjects having history of malignancy within the 5 years at the time of screening visit(except for treated basal cells carcinoma or squamous cell carcinoma)
- •18)Subjects having urinary tract disease as follows (urinary tract infection, neurogenic bladder)
- •19)Subjects having kidney disease as follows (nephritis, chronic glomerulonephritis or polycystic kidney disease)
- •20)Subjects having hypersensitivity or allergic reaction to Probucol
- •21)Subjects having HbA1c exceeding 9% at the time of screening
- •22)Subjects having systolic BP = 160 mmHg or diastolic BP = 100 mmHg at the time of screening
- •23)Subjects taken probucol within 3 months prior to screening
- •24)Subjects who has received another IMP within 3 months prior to screening
- •25)Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial due to reasons like alcohol or drug abuse
研究者
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