NCT00400439已完成2 期
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
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
- 77
- 主要终点
- Percent Change From Baseline in HDL-C
研究概览
简要总结
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have completed treatment on study NC19453.
排除标准
- •any significant lymph node abnormalities at the end of study NC19453.
研究组 & 干预措施
dalcetrapib (RO4607381)
Experimental
干预措施: dalcetrapib (RO4607381) (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in HDL-C
时间窗: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
次要结局
- Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)(Baseline and Week 24 (Week 48 from start of NC19453))
研究者
相似试验
已完成
2 期
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.Coronary Heart DiseaseNCT00353522Hoffmann-La Roche135
已完成
2 期
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent PatientsCoronary Heart DiseaseNCT00655538Hoffmann-La Roche476
已完成
3 期
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary SyndromeCoronary Heart DiseaseNCT00658515Hoffmann-La Roche15,871
已完成
不适用
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable AnginaStable AnginaNCT03742050Imperial College London439
终止
2 期
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)Facioscapulohumeral Muscular Dystrophy (FSHD)NCT04264442Fulcrum Therapeutics76