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

Primary Hypercholesterolemia Clinical Trial

Official title:

Orient Pharma Co., Ltd.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643093
• Other study ID #: OP-1PC111-301
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: October 5, 2021

Study information

• Verified date: May 2022
• Source: Orient Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: October 5, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemias
• Primary Hypercholesterolemia

Intervention

Drug:
• Pitavastatin
Pitavastatin, QD
• Ezetimibe
Ezetimibe, QD
• 1PC111
1PC111, QD

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Western Sydney	Blacktown
Australia	Northern Beaches Clinical Research	Brookvale
Australia	Emeritus Research	Camberwell
Australia	Paratus Clinical Research Central Coast	Kanwal
New Zealand	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	Culloden Research Ltd.	Tauranga
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chiayi Christian Hospital	Chiayi City
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.	Kaohsiung
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Kuang Tien General Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)	Tainan
Taiwan	Cathay General Hospital	Taipei
Taiwan	Cheng Hsin General Hospital	Taipei
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tamsui Mackay Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation- LinKuo Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Orient Pharma Co., Ltd.

Countries where clinical trial is conducted

Australia,  New Zealand,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients		12 week treatment period
Secondary	The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.		12 week treatment period