A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of TA-8995 in Patients With Mild Dyslipidaemia, Alone and In Combination With Statin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 364
- 试验地点
- 17
- 主要终点
- The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy.
The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.
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
- 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
- •Fasting LDL-C levels >2.5 mmol/L and <4.5 mmol/L, HDL-C levels <1.8 mmol/L and >0.8 mmol/L, and TG levels <4.5 mmol/L after run in or washout of existing therapies
- •Not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening
排除标准
- •Body mass index >32 kg/m2;
- •Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
- •Any clinical manifestation of atherosclerotic vascular disease;
- •Diagnosis of type 1 diabetes;
- •Uncontrolled type 2 diabetes: haemoglobin A1c >8%;
- •Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >90 mmHg;
- •History of hyperaldosteronism;
- •Active muscle disease or persistent creatine kinase concentration >3 × the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result;
研究组 & 干预措施
Group 5
TA-8995 10mg & placebo statin
干预措施: TA-8995 (Drug)
Group 5
TA-8995 10mg & placebo statin
干预措施: Placebo Statin (Drug)
Group 6
TA-8995 0mg (placebo) & atorvastatin 20mg
干预措施: Atorvastatin (Drug)
Group 6
TA-8995 0mg (placebo) & atorvastatin 20mg
干预措施: TA-8995 0mg (placebo) (Drug)
Group 7
TA-8995 10mg & atorvastatin 20mg
干预措施: TA-8995 (Drug)
Group 1
TA-8995 0mg (placebo) & placebo statin
干预措施: TA-8995 0mg (placebo) (Drug)
Group 1
TA-8995 0mg (placebo) & placebo statin
干预措施: Placebo Statin (Drug)
Group 2
TA-8995 1mg & placebo statin
干预措施: TA-8995 (Drug)
Group 2
TA-8995 1mg & placebo statin
干预措施: Placebo Statin (Drug)
Group 3
TA-8995 2.5mg & placebo statin
干预措施: TA-8995 (Drug)
Group 3
TA-8995 2.5mg & placebo statin
干预措施: Placebo Statin (Drug)
Group 4
TA-8995 5mg & placebo statin
干预措施: TA-8995 (Drug)
Group 4
TA-8995 5mg & placebo statin
干预措施: Placebo Statin (Drug)
Group 7
TA-8995 10mg & atorvastatin 20mg
干预措施: Atorvastatin (Drug)
Group 8
TA-8995 0mg (placebo) & rosuvastatin 10mg
干预措施: Rosuvastatin (Drug)
Group 8
TA-8995 0mg (placebo) & rosuvastatin 10mg
干预措施: TA-8995 0mg (placebo) (Drug)
Group 9
TA-8995 10mg & rosuvastatin 10mg
干预措施: TA-8995 (Drug)
Group 9
TA-8995 10mg & rosuvastatin 10mg
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
时间窗: 12 weeks
次要结局
未报告次要终点