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OpenTrials
Active, Not Recruiting

NCT Number: NCT07442630

Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

About this study

A multicenter study to evaluate efficacy and safety

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hypercholesterolemia
  • Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C

Exclusion criteria

  • New-onset acute cardio-cerebrovascular disease
  • Severe hepatic impairment
  • Active liver disease

Treatment and study plan

Pitavastatin 4mg

Drug

Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.

Ezetimibe 10 mg

Drug

Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.

Placebo (for Pitavastatin/Ezetimibe)

Drug

Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks.

Placebo (for Pitavastatin)

Drug

Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.

Primary outcomes

  1. Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment

    Time frame: Baseline to week 8

    The unit of measure is percentage (%). The percentage change is calculated as: [(Value at Week 8 - Value at Baseline) / Value at Baseline] * 100

Secondary outcomes

  1. Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment

    Time frame: Baseline to week 8, 24, 52

    Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL

  2. Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment

    Time frame: Baseline to week 8, 24, 52

    Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL

  3. Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment

    Time frame: Baseline to week 8, 24, 52

    Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL

  4. Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52

    Time frame: Baseline to week 24, 52

    The NLFS is a calculated score used to estimate liver fat content. The change is calculated as (Value at Week 24 or 52) - (Value at Baseline).

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Multicenter Study to Evaluate Efficacy and Safety

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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