CompletedPhase 3

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

Australia, New Zealand390 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. Primary hypercholesterolemia or mixed dyslipidemia
✓. Subject meeting All of the following diagnoses at Baseline visit:
✓. Subject who is willing and able to provide inform ed consent

Exclusion criteria

✕. Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
✕. Subject with documented HIV
✕. Subject with uncontrolled hypothyroidism according to the investigator's judgment
✕. 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
✕. 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
✕. Subject with the following medical histories:
✕. Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment
✕. Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)

What they're measuring

The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients

Timeframe: 12 week treatment period

Trial details

NCT IDNCT04643093

SponsorOrient Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-19

View on ClinicalTrials.gov More Primary Hypercholesterolemia trials