Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT ID: NCT04643093
Last Updated: 2022-05-18
Study Results
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Basic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2020-08-01
2021-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pitavastatin
Pitavastatin
Pitavastatin
Pitavastatin, QD
Ezetimibe
Ezetimibe
Ezetimibe
Ezetimibe, QD
1PC111
1PC111
1PC111
1PC111, QD
Interventions
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Pitavastatin
Pitavastatin, QD
Ezetimibe
Ezetimibe, QD
1PC111
1PC111, QD
Eligibility Criteria
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Inclusion Criteria
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
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)
20 Years
80 Years
ALL
No
Sponsors
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Orient Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Culloden Research Ltd.
Tauranga, , New Zealand
Changhua Christian Hospital
Changhua, , Taiwan
Chiayi Christian Hospital
Chiayi City, , Taiwan
E-Da Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
Kaohsiung City, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , 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 City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)
Tainan City, , 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 District, , Taiwan
Countries
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References
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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.
Other Identifiers
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OP-1PC111-301
Identifier Type: -
Identifier Source: org_study_id
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