NCT04643093已完成3 期
Orient Pharma Co., Ltd.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 34
- 主要终点
- The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
研究概览
简要总结
The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.
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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hypercholesterolemia or mixed dyslipidemia
- •Subject meeting All of the following diagnoses at Baseline visit:
- •TG≦350 mg/dL
- •ALT and AST≦ 2.5 times of upper limit of normal (ULN) with no acute liver disease
- •Creatine kinase (CK) concentration≦2 times of UL N
- •Creatinine≦1.5 mg/dL
- •Subject who is willing and able to provide inform ed consent
排除标准
- •Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
- •Subject with documented HIV
- •Subject with uncontrolled hypothyroidism according to the investigator's judgment
- •Subject with unstable cardiovascular disease (CVD), including but not limited to congestive heart failure (CHF) defined as New York Heart Association class III or IV, unstable angina, unstable arrhythmia according to the investigator's judgment
- •Subject with unstable hepatic or biliary disorders, including but not limited to acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice , and chronic hepatitis B or C under antiviral therapy
- •Subject with the following medical histories:
- •History of malignancy, exceptions made for the following malignancies: a)those determined to be cured or in remission for ≥ 5 years, b) curatively resected basal cell or squamous cell skin cancers, c) cervical cancer in situ, or resected colonic polyps
- •Acute coronary syndrome with or without cardiac catheterization within the past 9 months
- •Therapeutic cardiac catheterization (due to reasons other than acute coronary syndrome) within the past 6 months
- •Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment
- •Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
- •Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
- •Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
研究组 & 干预措施
Pitavastatin
Active Comparator
Pitavastatin
干预措施: Pitavastatin (Drug)
Ezetimibe
Active Comparator
Ezetimibe
干预措施: Ezetimibe (Drug)
1PC111
Experimental
1PC111
干预措施: 1PC111 (Drug)
结局指标
主要结局
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
时间窗: 12 week treatment period
次要结局
- The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.(12 week treatment period)
研究者
研究点 (34)
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