NCT05120895

An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

A Multicenter, Prospective, Non-interventional Observational Study to Investigate the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,060 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy and safety based on the observation of the blood cholesterol change with Mevalotin® Tablet administration in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Detailed description

In this prospective, observational study, patient data (eg, clinical outcomes in actual clinical settings, demographic information, medical treatment-related information, Mevalotin® Tablet administration start date \[Index date\], and the lipid profile results at Week 24 after Mevalotin® Tablet administration start date) will be collected from medical records. No study drug will be administered in this study. Patient data will be used to determine the change in blood cholesterol with Mevalotin® Tablet administration (5 mg, 10 mg, 20 mg, 40 mg as determined by Investigator in clinical practice) in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Mevalotin	Oral tablets (starting dose 5 mg)

Timeline

• Start date: 2021-08-10
• Primary completion: 2024-09-02
• Completion: 2024-12-27
• First posted: 2021-11-15
• Last updated: 2025-07-23

Locations

58 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study