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Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides
Sponsor: JW Pharmaceutical
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
Official title: A Multicenter Study to Evaluate Efficacy and Safety
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2023-08-21
Completion Date
2026-11-30
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Pitavastatin 4mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Ezetimibe 10 mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
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.
Placebo (for Pitavastatin)
Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.
Locations (1)
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea