Clinical trial NCT06293261: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
Official title: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Hypercholesterolemia
Keywords: long-term efficacy and safety of Rusuampin Tab
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 5047
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator

Brief summary: This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia

Detailed description: All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 19 years
2. Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
3. Written informed consent

Exclusion Criteria:

1. Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
2. A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman
3. a patient with severe liver failure
4. Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal
5. a patient with severe aortic valvular stenosis
6. a myopathy patient
7. a cyclosporine co-administered patient
8. a patient with severe renal failure (CLcr, creatinine clearance \<30 mL/min)

Primary outcomes:
measure: Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
timeFrame: Baseline, 12 Months
Secondary outcomes:
measure: Change from baseline to 6/12 months in SBP and DBP
timeFrame: Baseline, 6, 12 Months
measure: Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)
timeFrame: Baseline, 6, 12 Months
measure: Change from baseline to 6/12 months in hs-CRP
timeFrame: Baseline, 6, 12 Months
measure: Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)
timeFrame: Baseline, 6, 12 Months
measure: Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)
timeFrame: Baseline, 6, 12 Months
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Chungbuk
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chungnam
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center Eulji University
city: Goyang-si
country: Korea, Republic of
facility: Myungji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang Jesaeng General Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Cha University Bundang Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Gyeongsang
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Kwandong University International St.Mary'S Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Veterance Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Moohyun Kim
role: PRINCIPAL_INVESTIGATOR
References: