Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Mevalotin®
Menopause
Blood cholesterol
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Korea Co., Ltd.
First posted: 2021-11-15
Enrollment: 3300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
timeFrame: Week 24 post-dose
Secondary outcomes:
measure: Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
timeFrame: Week 24 post-dose
measure: 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
timeFrame: Week 24 post-dose
measure: 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
timeFrame: Week 48 post-dose
measure: 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
timeFrame: Week 48 post-dose
measure: Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration
timeFrame: Week 48 post-dose
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital - Site 0011
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital - Site 0031
city: Busan
country: Korea, Republic of
facility: Boneseng Memorial Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital - Site 0013
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital - Site 0033
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Medical Center - Chuncheon
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital - Site 0050
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital - Site 0004
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital - Site 0040
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital - Site 0022
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital - Site 0044
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital - Site 0049
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital Hwasun Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pohang
country: Korea, Republic of
facility: Pohang St. Mary's Hospital
city: Pohang
country: Korea, Republic of
facility: SM Christianity Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Jesaeng Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital - Site 0001
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital - Site 0019
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center - Site 0020
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center - Site 0039
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center-Kangnam
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center, Eulji University - Site 0053
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center, Eulji University
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan Univeristy Hospital
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital - Site 0051
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Yongin
country: Korea, Republic of
facility: Yonsei University Yongin Severance Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: