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

NCT04643093 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemias

Interventions

DRUG

Pitavastatin

Pitavastatin, QD

DRUG

Ezetimibe

Ezetimibe, QD

DRUG

1PC111

1PC111, QD

Sponsors & Collaborators

  • Orient Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-19
Completion
2021-10-05

Countries

  • Australia
  • New Zealand
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643093 on ClinicalTrials.gov