Clinical trial NCT04643093: Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Official title: Orient Pharma Co., Ltd.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemias
Keywords: Primary Hypercholesterolemia
Mixed Dyslipidemias
Lead sponsor: Orient Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-24
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
timeFrame: 12 week treatment period
Secondary outcomes:
measure: The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.
timeFrame: 12 week treatment period
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
city: Camberwell
country: Australia
facility: Emeritus Research
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
city: Auckland
country: New Zealand
facility: Southern Clinical Trials - Waitemata Ltd.
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Totara
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Group Ltd
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials Waikato
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Tasman
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials Rotorua
city: Tauranga
country: New Zealand
facility: Culloden Research Ltd.
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tamsui Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation- LinKuo Branch
Study officials:
References:
citation: Chou MT, McGirr A, Jong GP, Chao TH, Lee IT, Huang CY, Chen CP, Hsieh CH, Lu CH, Sheu WH. Effect of 1PC111, a Fixed-dose Combination of Pitavastatin and Ezetimibe, Versus Pitavastatin or Ezetimibe Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2022 Oct;44(10):1272-1281. doi: 10.1016/j.clinthera.2022.08.006. Epub 2022 Aug 25.