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

Orient Pharma

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemias; Primary Hypercholesterolemia

Treatments: Drug: Ezetimibe; Drug: Pitavastatin; Drug: 1PC111

Study type: Interventional

Funder types: Industry

Identifiers

NCT04643093

OP-1PC111-301

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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390 participants in 3 patient groups

Pitavastatin

Active Comparator group

Description:

Pitavastatin

Treatment:

Drug: Pitavastatin

Ezetimibe

Active Comparator group

Description:

Ezetimibe

Treatment:

Drug: Ezetimibe

1PC111

Experimental group

Description:

1PC111

Treatment:

Drug: 1PC111