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

• Sponsor: Orient Pharma Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04643093
• Collaborator: (none)
• Enrollment: 390
• Locations: 34
• Arms: 3
• Actual Duration (Months): 14.1
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia; Mixed Dyslipidemias	Drug: Pitavastatin; Drug: Ezetimibe; Drug: 1PC111	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-Blind
• Primary Purpose: Treatment
• Official Title: Orient Pharma Co., Ltd.
• Actual Study Start Date: Aug 1, 2020
• Actual Primary Completion Date: Aug 19, 2021
• Actual Study Completion Date: Oct 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pitavastatin Pitavastatin	Drug: Pitavastatin; Pitavastatin, QD
Active Comparator: Ezetimibe Ezetimibe	Drug: Ezetimibe; Ezetimibe, QD
Experimental: 1PC111 1PC111	Drug: 1PC111; 1PC111, QD

Outcome Measures

Primary Outcome Measures

1. The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients [12 week treatment period]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

1. 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

1. Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment

2. Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)

3. Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)

4. Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paratus Clinical Research Western Sydney	Blacktown		Australia
2	Northern Beaches Clinical Research	Brookvale		Australia
3	Emeritus Research	Camberwell		Australia
4	Paratus Clinical Research Central Coast	Kanwal		Australia
5	Southern Clinical Trials - Waitemata Ltd.	Auckland		New Zealand
6	Southern Clinical Trials Totara	Auckland		New Zealand
7	Southern Clinical Trials Group Ltd	Christchurch		New Zealand
8	Lakeland Clinical Trials Waikato	Hamilton		New Zealand
9	Southern Clinical Trials Tasman	Nelson		New Zealand
10	Lakeland Clinical Trials Rotorua	Rotorua		New Zealand
11	Culloden Research Ltd.	Tauranga		New Zealand
12	Changhua Christian Hospital	Changhua		Taiwan
13	Chiayi Christian Hospital	Chiayi City		Taiwan
14	E-Da Hospital	Kaohsiung		Taiwan
15	Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.	Kaohsiung		Taiwan
16	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan
17	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan
18	China Medical University Hospital	Taichung		Taiwan
19	Chung Shan Medical University Hospital	Taichung		Taiwan
20	Kuang Tien General Hospital	Taichung		Taiwan
21	Taichung Veterans General Hospital	Taichung		Taiwan
22	Chi Mei Medical Center	Tainan		Taiwan
23	National Cheng Kung University Hospital	Tainan		Taiwan
24	Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)	Tainan		Taiwan
25	Cathay General Hospital	Taipei		Taiwan
26	Cheng Hsin General Hospital	Taipei		Taiwan
27	Far Eastern Memorial Hospital	Taipei		Taiwan
28	National Taiwan University Hospital	Taipei		Taiwan
29	Shin Kong Wu Ho-Su Memorial Hospital	Taipei		Taiwan
30	Taipei Medical University Hospital	Taipei		Taiwan
31	Taipei Veterans General Hospital	Taipei		Taiwan
32	Tamsui Mackay Memorial Hospital	Taipei		Taiwan
33	Tri-Service General Hospital	Taipei		Taiwan
34	Chang Gung Medical Foundation- LinKuo Branch	Taoyuan		Taiwan

Sponsors and Collaborators

• Orient Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orient Pharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04643093
• Other Study ID Numbers: OP-1PC111-301
• First Posted: Nov 24, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Orient Pharma Co., Ltd.: Primary Hypercholesterolemia; Mixed Dyslipidemias
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias; Ezetimibe; Pitavastatin

Study Results

No Results Posted as of May 18, 2022