NCT00907998已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Safety and tolerability of APL180
研究概览
简要总结
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Male and female CHD or CHD equivalent patients
- •Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
- •Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.
- •Exclusion criteria:
- •Pregnancy
- •Significant illness within two weeks prior to dosing.
- •Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
- •Uncontrolled hypertension
- •Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
- •Presence of NYHA Class III or IV chronic heart failure
- •MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
APL180 (first dose level)
Experimental
干预措施: APL180 (Drug)
APL180 (second dose level)
Experimental
干预措施: APL180 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of APL180
时间窗: Throughout the study
次要结局
- Pharmacokinetics of APL180(Throughout the study)
- Evaluate effects of APL180 biomarkers(Throughout the study)
- Pharmacokinetic-pharmacodynamic relationship of APL180(Throughout the study)
- Effect of APL180 on exploratory biomarkers,(Throughout the study)
研究者
研究点 (4)
Loading locations...
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