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

Phase 4Active Not RecruitingNCT07442630

JW Pharmaceutical88 enrolled

Overview

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

A multicenter study to evaluate efficacy and safety

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Pitavastatin 4mgDRUG

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

Ezetimibe 10 mgDRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: Baseline to week 8

Secondary Outcomes

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

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

Time frame: Baseline to week 8, 24, 52

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

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

Time frame: 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

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

Time frame: Baseline to week 8, 24, 52

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

Time frame: Baseline to week 24, 52

Data from ClinicalTrials.gov

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