Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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Orient Pharma Co., Ltd.

Conditions
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Primary Hypercholesterolemia, Mixed Dyslipidemias

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Ezetimibe
* Drug: 1PC111


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pitavastatin<br>Pitavastatin | Drug: Pitavastatin<br>* Pitavastatin, QD<br>|
| Active Comparator: Ezetimibe<br>Ezetimibe | Drug: Ezetimibe<br>* Ezetimibe, QD<br>|
| Experimental: 1PC111<br>1PC111 | Drug: 1PC111<br>* 1PC111, QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients |  | 12 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period. |  | 12 week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Hypercholesterolemia, Mixed Dyslipidemias