NCT01029522已完成4 期
A Multi-center, Randomized, Double-blinded Equivalence Clinical Trial to Evaluate Efficacy and Safety of LipiLou 20 mg Versus Lipitor 20 mg in Hypercholesterolemic Patients With Higher Risk Cardiovascular Disease in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 244
- 主要终点
- LDL-C
研究概览
简要总结
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease
- •diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease
- •Aged 20~85 years
- •Volunteers consented with participating clinical trial and submitted consent paper
排除标准
- •Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase > 2 x ULN 3) Creatinine > 2.5mg/dL 4) Triglycerides > 500mg/dL
- •intervened with stent in coronary artery disease less than 1 year before
- •Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
- •Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
- •As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
- •DBP > 100mmHg, SBP > 160mmHg
- •Diagnosed with myopathy
- •Appear to be a risk of myopathy below
- •renal impairment or prior renal dysfunction
- •hypothyroidism
- •genetic defects or family history of myopathy
- •experienced prior muscle toxicity with taking statins or fibrates
- •prior liver disease or higher intakes of alcohol
- •aged over 70, and a risk of myopathy
- •Women pregnant or breast-feeding
- •Women capable of pregnancy without using contraceptives
- •contra-indicated medically or mentally, or forbidden legally
- •Enrolled to other clinical trial within 4 weeks
- •Impossible to participate clinical trial according to investigator's decision
研究组 & 干预措施
Lipilou 20mg
Experimental
干预措施: Atorvastatin (Lipilou) (Drug)
Lipitor 20mg
Active Comparator
干预措施: Atorvastatin (Lipitor) (Drug)
结局指标
主要结局
LDL-C
时间窗: after taken medicine for 8 weeks
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
2 期
RSYR for Fatigue Reduction in Cancer Fatigue Caused by ChemotherapyCancer-related Problem/ConditionNCT05229029Peking University Cancer Hospital & Institute196
已完成
不适用
Treatment of Knee Osteoarthritis With PAAG-OAOsteoarthritis, KneeNCT04045431Contura238
已完成
2 期
A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory InfectionsViral Respiratory InfectionAcute Viral Upper Respiratory InfectionsInfluenzaNCT05030324Valenta Pharm JSC255
终止
3 期
Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated HaemorrhoidsHaemorrhoids Without ComplicationNCT05788497Faes Farma, S.A.21
Unknown
3 期
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid TumorsBone MetastasesNCT04550949Qilu Pharmaceutical Co., Ltd.700