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
- Registration Number
- NCT05120895
- Lead Sponsor
- Daiichi Sankyo
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3300
-
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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mevalotin Mevalotin Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.
- Primary Outcome Measures
Name Time Method Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration Week 24 post-dose The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
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 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.
Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration Week 48 post-dose 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.
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 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.
Trial Locations
- Locations (58)
Inje University Haeundae Paik Hospital - Site 0031
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital - Site 0033
🇰🇷Busan, Korea, Republic of
Hallym University Medical Center - Chuncheon
🇰🇷Chuncheon, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si, Korea, Republic of
Bucheon Sejong Hospital
🇰🇷Bucheon, Korea, Republic of
Pusan National University Hospital - Site 0013
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital - Site 0011
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Boneseng Memorial Hospital
🇰🇷Busan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Korea, Republic of
Hanyang University Guri Hospital - Site 0049
🇰🇷Guri, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Uijeongbu Eulji Medical Center, Eulji University
🇰🇷Uijeongbu, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Kangwon National University Hospital - Site 0050
🇰🇷Chuncheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷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
Hanyang University Guri Hospital - Site 0022
🇰🇷Guri, Korea, Republic of
Hanyang University Guri Hospital - Site 0044
🇰🇷Guri, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital Hwasun Hospital
🇰🇷Gwangju, Korea, Republic of
VHS Medical Center - Site 0020
🇰🇷Seoul, Korea, Republic of
Bundang Jesaeng Hospital
🇰🇷Seongnam-si, Korea, Republic of
VHS Medical Center - Site 0039
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan Univeristy Hospital
🇰🇷Ulsan, Korea, Republic of
Uijeongbu Eulji Medical Center, Eulji University - Site 0053
🇰🇷Uijeongbu, Korea, Republic of
Yonsei University Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Pohang St. Mary's Hospital
🇰🇷Pohang, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Korea, Republic of
SM Christianity Hospital
🇰🇷Pohang, 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
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Hallym University Medical Center-Kangnam
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital - Site 0051
🇰🇷Wŏnju, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of