NCT01726816已完成2 期
A Phase II, Multicenter, Randomized, Double Blind, Double-dummy, 16-week, Placebo Controlled Study to Evaluate the Efficacy and Safety of Probucol in Patients With Nephropathy Due to Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 16
- 主要终点
- A/C ratio
研究概览
简要总结
This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.
- Screening period (4 week)
- Double blind treatment period (16 weeks)
详细描述
- Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner
- Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female diagnosed with type 2 diabetes mellitus and must be aged 20 to 75 years at the time of screening visit
- •Urinary albumin excretion > 300 mg/g Cr at screening visit
- •Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
- •Subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin)
- •15 mL/min ≤ eGFR ≤ 90 mL min
- •Subjects must be willing and able to give signed and dated written informed consent.
排除标准
- •Type 1 DM or gestational diabetes
- •Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
- •Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
- •Cardiac damage (abnormally levels of Troponin I)
- •Subject with medical history of cardiac syncope or primary syncope
- •Has condition that may prolong QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec) at screening
- •Pregnant or lactating woman before randomization
- •Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- •Cholestasis
- •Congestive heart failure
- •Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
- •Subjects has a diagnosis of NYHA grade III-IV status
- •AST or ALT is 3.0 times higher than the upper limit of the normal range
- •Active hepatitis Or Liver cirrhosis
- •Subjects with Hyperkalemia (K>5.5 mEq/L)
- •Subjects with Renal Artery stenosis
- •Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
- •Urinary tract disease (urinary tract infection, Neurogenic bladder)
- •Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
- •Has an allergic history to probucol
- •HbA1c > 9%
- •Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
- •Subjects taken probucol within 3 months prior to Screening
- •The subject has received an investigational product or biological agent within 3 months prior to screening
- •Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
研究组 & 干预措施
Probucol 250mg/day
Experimental
Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks
干预措施: Probucol 250mg/day (Drug)
Probucol 500mg/day
Experimental
Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks
干预措施: Probucol 500mg/day (Drug)
Placebo
Placebo Comparator
Placebo group: placebo 2 tablets, 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
A/C ratio
时间窗: 16 week
The change in the A/C ratio from baseline to the end of treatment(16 week) \[Time Frame: baseline to 16 weeks\]
次要结局
- eGFR(16 week)
- Serum creatinine(16 week)
- cystatin C(16 week)
- urine albumin(16 week)
- P/C ratio(16 week)
研究者
研究点 (16)
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