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

NCT05120895 | Completed FDA Drug

• 1 other identifier: MVT-OS-21-01
• Study Type: observational
• Target: 3,060
• Locations: 1 country
• Sites: 58

Brief 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.

Conditions

Dyslipidemia

Keywords

Dyslipidemia; Mevalotin®; Menopause; Blood cholesterol

Outcome Measures

Primary Outcomes (1)

• Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration

  The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.

  Week 24 post-dose

Secondary Outcomes (5)

• Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration

  Week 24 post-dose

• Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration

  Week 24 post-dose

• Change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration

  Week 48 post-dose

• Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration

  Week 48 post-dose

• Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration

  Week 48 post-dose

Study Arms (1)

Mevalotin

Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.

Drug: Mevalotin

Interventions

Mevalotin DRUG

Oral tablets (starting dose 5 mg)

Mevalotin

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Only Korean women are eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include Korean menopausal women aged 50 years or more who are prescribed with Mevalotin® Tablet at the medical discretion of an investigator as part of routine medical practice.

You may qualify if:

• Menopausal women aged 50 years or more diagnosed with dyslipidemia
• Menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the Mevalotin® Tablet administration start date (Index date).
• Patients who are determined to be prescribed with Mevalotin® Tablet at the discretion of an investigator or patients who started Mevalotin® Tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study)
• Patients who provided voluntary written consent to take part in this observational study

You may not qualify if:

• Patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.)
• Patients who received hormone replacement therapy within 1 year of enrollment
• Patients who are determined to be ineligible for participation in this observational study

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (58)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 14584, South Korea

Location

Bucheon Sejong Hospital

Bucheon-si, 14754, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital - Site 0011

Busan, 48108, South Korea

Location

Inje University Haeundae Paik Hospital - Site 0031

Busan, 48108, South Korea

Location

Boneseng Memorial Hospital

Busan, 48775, South Korea

Location

Pusan National University Hospital - Site 0013

Busan, 49241, South Korea

Location

Pusan National University Hospital - Site 0033

Busan, 49241, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Hallym University Medical Center - Chuncheon

Chuncheon, 24253, South Korea

Location

Kangwon National University Hospital - Site 0050

Chuncheon, 24289, South Korea

Location

Kangwon National University Hospital

Chuncheon, 24289, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Eulji University Hospital - Site 0004

Daejeon, 35233, South Korea

Location

Eulji University Hospital - Site 0040

Daejeon, 35233, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, 10380, South Korea

Location

Myongji Hospital

Goyang-si, 10475, South Korea

Location

Hanyang University Guri Hospital - Site 0022

Guri-si, 11923, South Korea

Location

Hanyang University Guri Hospital - Site 0044

Guri-si, 11923, South Korea

Location

Hanyang University Guri Hospital - Site 0049

Guri-si, 11923, South Korea

Location

Chonnam National University Hospital Hwasun Hospital

Gwangju, 58128, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

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

Incheon, 21431, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Location

Pohang St. Mary's Hospital

Pohang, 37661, South Korea

Location

SM Christianity Hospital

Pohang, 37816, South Korea

Location

Bundang Jesaeng Hospital

Seongnam-si, 13590, South Korea

Location

Seoul National University Bundang Hospital - Site 0001

Seongnam-si, 13620, South Korea

Location

Seoul National University Bundang Hospital - Site 0019

Seongnam-si, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, 03181, South Korea

Location

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

Seoul, 03312, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

VHS Medical Center - Site 0020

Seoul, 05368, South Korea

Location

VHS Medical Center - Site 0039

Seoul, 05368, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018

Seoul, 06591, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024

Seoul, 06591, South Korea

Location

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

Seoul, 06591, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Seoul, 06973, South Korea

Location

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

Seoul, 07345, South Korea

Location

Hallym University Medical Center-Kangnam

Seoul, 07441, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, 16247, South Korea

Location

Ajou University Hospital

Suwon, 16500, South Korea

Location

Uijeongbu Eulji Medical Center, Eulji University - Site 0053

Uijeongbu-si, 11759, South Korea

Location

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, 11759, South Korea

Location

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

Uijeongbu-si, 11765, South Korea

Location

Ulsan Univeristy Hospital

Ulsan, 44033, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital - Site 0051

Wŏnju, 26426, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Yonsei University Yongin Severance Hospital

Yŏngin, 16995, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 15, 2021
• Study Start: August 10, 2021
• Primary Completion: September 2, 2024
• Study Completion: December 27, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (58)