NCT00465088已完成3 期
SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 199
- 主要终点
- Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
研究概览
简要总结
To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following laboratory criteria:
- •HDL-C <40 mg/dL for men and <50 mg/dL for women.
- •LDL-C ≥130 mg/dL but <250 mg/dL.
- •TG <350 mg/dL.
- •Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).
- •Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN.
- •Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).
排除标准
- •Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion
研究组 & 干预措施
1
Experimental
干预措施: Niacin ER/Simvastatin Tablets (Drug)
2
Experimental
干预措施: atorvastatin (Drug)
结局指标
主要结局
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
时间窗: From baseline to Week 12
(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
次要结局
- Percent Change in HDL-C From Baseline to Week 8(From baseline to Week 8)
- Percent Change in Non-HDL-C From Baseline to Week 8(From baseline to Week 8)
- Percent Change in Non-HDL-C From Baseline to Week 12(From baseline to Week 12)
- Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12(From baseline to Week 12)
- Percent Change in Triglycerides From Baseline to Week 12(From baseline to Week 12)
- Percent Change in LDL-C:HDL-C Ratio(From baseline to Week 12)
- Percent Change in Total Cholesterol From Baseline to Week 12(From baseline to Week 12)
- Percent Change in Total Cholesterol:HDL-C Ratio(From baseline to Week 12)
- Percent Change in Lipoprotein A From Baseline to Week 12(From baseline to Week 12)
- Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12(12 weeks)
- Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12(12 weeks)
- Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12(12 weeks)
- Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12(12 weeks)
研究者
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