NCT07442630

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

A Multicenter Study to Evaluate Efficacy and Safety

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A multicenter study to evaluate efficacy and safety

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Pitavastatin 4mg	Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
DRUG	Ezetimibe 10 mg	Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
DRUG	Placebo (for Pitavastatin/Ezetimibe)	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.
DRUG	Placebo (for Pitavastatin)	Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.

Timeline

• Start date: 2023-08-21
• Primary completion: 2026-01-22
• Completion: 2026-11-30
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: South Korea