NCT00858637已完成3 期
A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 39
- 主要终点
- Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
研究概览
简要总结
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, and is >=18 years old
- •Stable hemodialysis or peritoneal dialysis
- •Subjects undergoing regular dialysis treatment
- •If Female and of child-bearing potential, have a negative serum pregnancy test
- •Male subjects must agree to use appropriate contraception
排除标准
- •Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study
- •Serum albumin level < 30 g/L
- •Triglycerides level > 6.76 mmol/L (600 mg/dL)
- •LDL-cholesterol level > 4.94 mmol/L (190 mg/dL)
- •A History of significant gastrointestinal motility problems
- •Biliary obstruction or proven liver dysfunction
- •A positive test for HIV 1 and 2 antibodies
- •A history of substance or alcohol abuse within the last year
- •The subject has a history of rhabdomyolysis or myopathy
- •Schedule to receive a kidney transplant within the next 6 months
- •The subject has porphyria
- •Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
研究组 & 干预措施
4 Placebo of Simvastatin
Placebo Comparator
干预措施: Placebo of MCI-196 (Drug)
2 Placebo of MCI-196
Placebo Comparator
干预措施: Placebo of MCI-196 (Drug)
3 Simvastatin
Active Comparator
干预措施: Placebo of MCI-196 (Drug)
1 MCI-196
Experimental
干预措施: MCI-196 (Drug)
4 Placebo of Simvastatin
Placebo Comparator
干预措施: Placebo of Simvastatin (Drug)
3 Simvastatin
Active Comparator
干预措施: Simvastatin (Drug)
2 Placebo of MCI-196
Placebo Comparator
干预措施: Placebo of Simvastatin (Drug)
1 MCI-196
Experimental
干预措施: Placebo of Simvastatin (Drug)
结局指标
主要结局
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
时间窗: week20 minus week16
Percent Change from Week 16 to Week 20 (LOCF)
次要结局
- Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)(week16 minus week0)
- Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)(16 weeks and 20 weeks)
- Vital Signs, Adverse Events, and Laboratory Values(throughout study)
研究者
研究点 (39)
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