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A Randomized, Double-blind, Multicenter, Phase III Study Assessing the 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

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Trial Profile

A Randomized, Double-blind, Multicenter, Phase III Study Assessing the 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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2022

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At a glance

  • Drugs Ezetimibe/pitavastatin (Primary) ; Ezetimibe; Pitavastatin
  • Indications Dyslipidaemias; Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Orient Pharma
  • Most Recent Events

    • 24 Aug 2022 Primary endpoint (The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients) has been met as per the results published in the Clinical Therapeutics
    • 24 Aug 2022 Results published in the Clinical Therapeutics
    • 17 May 2022 Status changed from active, no longer recruiting to completed.

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