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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemias
• Interventions: Drug: 1PC111; Drug: Pitavastatin; Drug: Ezetimibe

• Registration Number: NCT04643093
• Lead Sponsor: Orient Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-11-22
• Study First Posted: 2020-11-24
• Primary Completion: 2021-08-19
• Study Completion: 2021-10-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1PC111	1PC111	1PC111
Pitavastatin	Pitavastatin	Pitavastatin
Ezetimibe	Ezetimibe	Ezetimibe

Primary Outcome Measures

Name	Time	Method
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients	12 week treatment period

Secondary Outcome Measures

Name	Time	Method
The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.	12 week treatment period

Trial Locations

Locations (34)

Paratus Clinical Research Western Sydney; 🇦🇺 Blacktown, Australia

Northern Beaches Clinical Research; 🇦🇺 Brookvale, Australia

Emeritus Research; 🇦🇺 Camberwell, Australia

Paratus Clinical Research Central Coast; 🇦🇺 Kanwal, Australia

Southern Clinical Trials - Waitemata Ltd.; 🇳🇿 Auckland, New Zealand

Southern Clinical Trials Totara; 🇳🇿 Auckland, New Zealand

Southern Clinical Trials Group Ltd; 🇳🇿 Christchurch, New Zealand

Lakeland Clinical Trials Waikato; 🇳🇿 Hamilton, New Zealand

Southern Clinical Trials Tasman; 🇳🇿 Nelson, New Zealand

Lakeland Clinical Trials Rotorua; 🇳🇿 Rotorua, New Zealand

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