NCT00214604已完成3 期
An 18-week, Randomized, Multicenter, Phase 3b, Double-blind, Crossover Study, Followed by an 18-week Open-Label Period to Evaluate the Efficacy & Safety of the Lipid-Regulating Agents, Rosuvastatin & Pravastatin in the Treatment of Subjects With Dysbetalipoproteinemia (Frederickson Type III Hyperlipoproteinemia)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period.
研究概览
简要总结
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio >0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia
排除标准
- •Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine > 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride > 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.
结局指标
主要结局
Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period.
次要结局
- Efficacy of once daily treatment with rosuvastatin 10mg, rosuvastatin 20mg and provastatin 40mg in subjects with dysbetalipoproteinemia after 6 weeks of treatment at any given dose during the 18-week randomized crossover period.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin TherapyHypercholesteremiaNCT00239330AstraZeneca824
已完成
3 期
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)HypercholesterolemiaNCT00654173AstraZeneca4,444
已完成
3 期
Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb HypercholesterolemiaHypercholesterolemiaNCT00654407AstraZeneca4,875
已完成
3 期
STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose RangesHypercholesterolemiaNCT00654537AstraZeneca5,625
Unknown
4 期
Efficacy and Safety Study of 5 mg and 10 mg RosuvastatinDyslipidemiaNCT01613729D16 Pharma & Biotec Ltd.2,000