Mixed Dyslipidemias, Primary Hypercholesterolemia
Conditions
Keywords
Primary Hypercholesterolemia, Mixed Dyslipidemias
Brief summary
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.
Interventions
DRUGPitavastatin
Pitavastatin, QD
DRUGEzetimibe
Ezetimibe, QD
DRUG1PC111
1PC111, QD
Sponsors
Orient Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Primary hypercholesterolemia or mixed dyslipidemia 2. 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 3. Subject who is willing and able to provide inform ed consent
Exclusion criteria
1. Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception. 2. Subject with documented HIV 3. Subject with uncontrolled hypothyroidism according to the investigator's judgment 4. 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 5. 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 6. 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 7. Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment 8. Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1) 9. Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1) 10. Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients | 12 week treatment period |
Secondary
| Measure | 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 |
Countries
Australia, New Zealand, Taiwan
Outcome results
None listed