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NCT05120895 Clinical Trial

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

Dyslipidemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05120895
Other study ID # MVT-OS-21-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date April 30, 2025

Study information
Verified date June 2024
Source Daiichi Sankyo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3300
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mevalotin
Oral tablets (starting dose 5 mg)

Locations
Country Name City State
Korea, Republic of Bucheon Sejong Hospital Bucheon
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon-si
Korea, Republic of Boneseng Memorial Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital - Site 0011 Busan
Korea, Republic of Inje University Haeundae Paik Hospital - Site 0031 Busan
Korea, Republic of Pusan National University Hospital - Site 0013 Busan
Korea, Republic of Pusan National University Hospital - Site 0033 Busan
Korea, Republic of Chungbuk National University Hospital Cheongju-si
Korea, Republic of Hallym University Medical Center - Chuncheon Chuncheon
Korea, Republic of Kangwon National University Hospital Chuncheon
Korea, Republic of Kangwon National University Hospital - Site 0050 Chuncheon
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Eulji University Hospital - Site 0004 Daejeon
Korea, Republic of Eulji University Hospital - Site 0040 Daejeon
Korea, Republic of Konyang University Hospital Daejeon
Korea, Republic of Inje University Ilsan Paik Hospital Goyang-si
Korea, Republic of Myongji Hospital Goyang-si
Korea, Republic of Hanyang University Guri Hospital - Site 0022 Guri
Korea, Republic of Hanyang University Guri Hospital - Site 0044 Guri
Korea, Republic of Hanyang University Guri Hospital - Site 0049 Guri
Korea, Republic of Chonnam National University Hospital Hwasun Hospital Gwangju
Korea, Republic of Chosun University Hospital Gwangju
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of The Catholic University of Korea, Incheon St. Mary's Hospital Incheon
Korea, Republic of Gyeongsang National University Hospital Jinju
Korea, Republic of Pohang St. Mary's Hospital Pohang
Korea, Republic of SM Christianity Hospital Pohang
Korea, Republic of Bundang Jesaeng Hospital Seongnam-si
Korea, Republic of Seoul National University Bundang Hospital - Site 0001 Seongnam-si
Korea, Republic of Seoul National University Bundang Hospital - Site 0019 Seongnam-si
Korea, Republic of Chung-Ang University Gwangmyeong Hospital Seoul
Korea, Republic of Hallym University Medical Center-Kangnam Seoul
Korea, Republic of Hanyang University Seoul Hospital Seoul
Korea, Republic of Kangbuk Samsung Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Soon Chun Hyang University Hospital Seoul Seoul
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018 Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024 Seoul
Korea, Republic of The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul
Korea, Republic of VHS Medical Center - Site 0020 Seoul
Korea, Republic of VHS Medical Center - Site 0039 Seoul
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon
Korea, Republic of Ajou University Hospital Suwon-si
Korea, Republic of The Catholic University of Korea, Uijeongbu St. Mary's Hospital Uijeongbu
Korea, Republic of Uijeongbu Eulji Medical Center, Eulji University Uijeongbu
Korea, Republic of Uijeongbu Eulji Medical Center, Eulji University - Site 0053 Uijeongbu
Korea, Republic of Ulsan Univeristy Hospital Ulsan
Korea, Republic of Yonsei University, Wonju Severance Christian Hospital Wonju
Korea, Republic of Yonsei University, Wonju Severance Christian Hospital - Site 0051 Wonju
Korea, Republic of Pusan National University Yangsan Hospital Yangsan
Korea, Republic of Yonsei University Yongin Severance Hospital Yongin

Sponsors (2)
Lead Sponsor Collaborator
Daiichi Sankyo Daiichi Sankyo Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples. Week 24 post-dose
Secondary 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 The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples. Week 24 post-dose
Secondary 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 The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples. Week 48 post-dose
Secondary 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 The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples. Week 48 post-dose
Secondary Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration Treatment-emergent adverse event (TEAE) is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. Week 48 post-dose
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