Clinical Trials List
2020-08-01 - 2021-08-19
Phase III
Not yet recruiting4
Recruiting19
ICD-10E78.0
Pure hypercholesterolemia
ICD-10E78.5
Hyperlipidemia, unspecified
A Phase III, Prospective, Multi-center, Double-blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of Pitavastatin 2 mg/ Ezetimibe 10 mg with Pitavastatin and Ezetimibe in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia
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Trial Applicant
Orient PHARMA Co., Ltd.
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Sponsor
Orient Pharma Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Condition/Disease
Objectives
Test Drug
Active Ingredient
pitavastatin
Dosage Form
capsule
Dosage
Endpoints
1. Primary endpoint(s):
To compare
(1) pitavastatin 2 mg plus ezetimibe 10 mg vs. pitavastatin 2 mg ;
(2) pitavastatin 2 mg plus ezetimibe 10 mg vs. ezetimibe 10 mg ;
Mean percentage change from Baseline in LDL-C level at Week 12
2. Secondary endpoints:
To compare the following parameters for
1. pitavastatin 2 mg plus ezetimibe 10 mg vs. pitavastatin 2 mg ;
2. pitavastatin 2 mg plus ezetimibe 10 mg vs. ezetimibe 10 mg ;
(1) Mean percentage change from Baseline in LDL-C level at Week 4 and Week 8
(2) Mean percentage change from Baseline in TC level at Week 8 and Week 12
(3) Mean percentage change from Baseline in HDL-C level at Week 8 and Week 12
(4) Mean percentage change from Baseline in TG level at Week 8 and Week 12
(5) Mean percentage change from Baseline in non-HDL-C level at Week 12
(6) Mean change from Baseline in the ratio of LDL-C/HDL-C at Week 12
(7) Mean change from Baseline in the ratio of TC/HDL-C at Week 12
(8) Mean change from Baseline in Apo A1 and Apo B level at Week 4 and Week 12
(9) Mean change from Baseline in Apo B/Apo A1 ratio at Week 4 and Week 12
(10) Mean change from Baseline in remnant-like particle cholesterol (RLP-C) at Week 12
Inclution Criteria
(2) Subject meeting All of the following diagnoses:
Primary hypercholesterolemia or mixed dyslipidemia
130 mg/dL≦ LDL-C ≦ 250 mg/dL at both Screening and Baseline visit
Alternatively, subject with 100 mg/dL ≦LDL-C≦ 250 mg/dL at Screening visit is acceptable if he/she is with lipid-lowering treatment, but the subject must have LDL-C ≥ 130 mg/dL and ≤ 250 mg/dL at Baseline visit to be eligible.
(3) 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 ULN
Creatinine≦ 1.5 mg/dL
HbA1c ≦ 8.0%
(4) Subject who is willing and able to provide informed consent
Exclusion Criteria
*Subjects taking oral contraceptive agents or contraceptive patch should NOT be enrolled, since those will cause fluctuation in plasma lipid and lipoprotein level
(2) Subject with habitual alcohol consumption > 14 units per week regularly for more than 1 year
Kind of Alcohol Alcohol Percentage mL per 1 unit = 8 g of pure alcohol
Beer 5% 200 mL
Whiskey/Brandy 40% 25 mL
Wine 12% approx. 83 mL
Sake 15% approx. 67 mL
Distilled spirit 25% 40 mL
Kaoliang 50% 20 mL
(3) Subject with documented homozygous familial hypercholesterolemia
(4) Subject with documented secondary hypercholesterolemia
(5) Subject with documented HIV
(6) Subject with uncontrolled hypothyroidism according to the investigator’s judgment
(7) Subject with unstable cardiovascular disease (CVD), including but not limited to uncontrolled congestive heart failure (CHF) defined as New York Heart Association class III or IV, unstable angina, or uncontrolled arrhythmia according to the investigator’s judgment
(8) 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
(9) Subject with the following medical histories:
Hypersensitivity to statins, ezetimibe, or any other ingredients of the study drug
Intolerant to statins treatment
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
(10) Any unstable comorbidities or clinical conditions, including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation, per investigatiors’ judgment
(11) Use any lipid-lowering agent within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
(12) Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
(13) Use any investigational product within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
The Estimated Number of Participants
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Taiwan
384 participants
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Global
384 participants
