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

May 17, 2022 updated by: Orient Pharma Co., Ltd.

Orient Pharma Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Blacktown, Australia
        • Paratus Clinical Research Western Sydney
      • Brookvale, Australia
        • Northern Beaches Clinical Research
      • Camberwell, Australia
        • Emeritus Research
      • Kanwal, Australia
        • Paratus Clinical Research Central Coast
  • New Zealand
      • Auckland, New Zealand
        • Southern Clinical Trials - Waitemata Ltd.
      • Auckland, New Zealand
        • Southern Clinical Trials Totara
      • Christchurch, New Zealand
        • Southern Clinical Trials Group Ltd
      • Hamilton, New Zealand
        • Lakeland Clinical Trials Waikato
      • Nelson, New Zealand
        • Southern Clinical Trials Tasman
      • Rotorua, New Zealand
        • Lakeland Clinical Trials Rotorua
      • Tauranga, New Zealand
        • Culloden Research Ltd.
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Chiayi City, Taiwan
        • Chiayi Christian Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan
        • E-DA Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan
        • Kuang Tien General Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Tainan, Taiwan
        • Chi Mei Medical Center
      • Tainan, Taiwan
        • Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan
        • Cheng Hsin General Hospital
      • Taipei, Taiwan
        • Cathay General Hospital
      • Taipei, Taiwan
        • Shin Kong Wu Ho-Su Memorial Hospital
      • Taipei, Taiwan
        • Tamsui MacKay Memorial Hospital
      • Taoyuan, Taiwan
        • Chang Gung Medical Foundation- LinKuo Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
Time Frame: 12 week treatment period
12 week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.
Time Frame: 12 week treatment period
12 week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orient Pharma Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

August 19, 2021

Study Completion (Actual)

October 5, 2021

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP-1PC111-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypercholesterolemia

Clinical Trials on Pitavastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe