NCT07442630

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
6mo left

Started Aug 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2023Nov 2026

Study Start

First participant enrolled

August 21, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Hypercholesterolemia

Keywords

LDL Cholesterol Reduction

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline to week 8

Secondary Outcomes (4)

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

    Baseline to week 8, 24, 52

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

    Baseline to week 8, 24, 52

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

    Baseline to week 8, 24, 52

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

    Baseline to week 24, 52

Study Arms (2)

Pitavastatin/Ezetimibe Combination

EXPERIMENTAL

FDC of Pitavastatin/Ezetimibe

Drug: Pitavastatin 4mgDrug: Ezetimibe 10 mgDrug: Placebo (for Pitavastatin)

Pitavastatin Monotherapy

ACTIVE COMPARATOR

Pitavastatin

Drug: Pitavastatin 4mgDrug: Placebo (for Pitavastatin/Ezetimibe)

Interventions

Pitavastatin 4mgDRUG

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

Pitavastatin MonotherapyPitavastatin/Ezetimibe Combination
Ezetimibe 10 mgDRUG

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

Pitavastatin/Ezetimibe Combination
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.

Pitavastatin Monotherapy
Placebo (for Pitavastatin)DRUG

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

Pitavastatin/Ezetimibe Combination

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

pitavastatinEzetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hyuk Sang Kwon

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
To maintain the double-blind, a double-dummy method was used where participants received both an active tablet and a matching placebo of the comparator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double-blind, phase IV
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 2, 2026

Study Start

August 21, 2023

Primary Completion

January 22, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)