NCT01058083已完成2 期
A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Lowering of LDL-C
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Hypercholesterolemia
- •Currently taking a stable daily dose of statin therapy
- •Serum triglyceride level < 500mg/dl
- •Exclusion Criteria
- •History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
- •Congestive heart failure
- •Diabetes mellitus
- •Active liver disease
- •Impaired renal function
- •Hepatitis C, B and HIV
- •This list is not inclusive additional information is provided in the protocol
排除标准
- 未提供
研究组 & 干预措施
BMS-770767 (Treatment A)
Experimental
干预措施: BMS-770767 (Drug)
BMS-770767 (Treatment B)
Experimental
干预措施: BMS-770767 (Drug)
BMS-770767 (Treatment C)
Experimental
干预措施: BMS-770767 (Drug)
BMS-770767 (Treatment D)
Experimental
干预措施: BMS-770767 (Drug)
Placebo (Treatment E)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Lowering of LDL-C
时间窗: Within 28 days following dosing
次要结局
- Pharmacokinetics (Blood Level) of BMS-770767(Within 28 days following dosing)
- Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)(Within 28 days following dosing)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Safety Study of BMS-823778 in Subjects With HypercholesterolemiaDyslipidemiaNCT01112423Bristol-Myers Squibb60
已完成
2 期
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese SubjectsHypercholesterolemiaNCT02055976Pfizer218
已完成
2 期
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin IntoleranceHypercholesterolemiaNCT01751984Esperion Therapeutics, Inc.56
已完成
2 期
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With HypercholesterolemiaHypercholesterolemiaNCT04784442Otsuka Pharmaceutical Co., Ltd.188
终止
3 期
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With HypercholesterolemiaHypercholesterolemiaNCT00532558Takeda657