Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
- Conditions
- HypertensionHypercholesterolemia
- Interventions
- Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
- Registration Number
- NCT06293261
- Lead Sponsor
- Yuhan Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5047
- Aged β₯ 19 years
- Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
- Written informed consent
- Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
- 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
- a patient with severe liver failure
- 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
- a patient with severe aortic valvular stenosis
- a myopathy patient
- a cyclosporine co-administered patient
- a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg) Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg - Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg) Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg - Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg) Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg - Rosuampin 10/10mg (Rosuvastatin Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg -
- Primary Outcome Measures
Name Time Method Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) Baseline, 12 Months
- Secondary Outcome Measures
Name Time Method Change from baseline to 6/12 months in hs-CRP Baseline, 6, 12 Months Change from baseline to 6/12 months in SBP and DBP Baseline, 6, 12 Months Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C) Baseline, 6, 12 Months Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose) Baseline, 6, 12 Months Change from baseline to 6/12 months in Diabetes indicator ( HbA1c) Baseline, 6, 12 Months
Trial Locations
- Locations (39)
Dong-A University Hospital
π°π·Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
π°π·Changwon, Korea, Republic of
Daegu Catholic University Medical Center
π°π·Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
π°π·Daegu, Korea, Republic of
Dankook University Hospital
π°π·Chungnam, Korea, Republic of
Ewha Womans University Seoul Hospital
π°π·Seoul, Korea, Republic of
Ulsan University
π°π·Ulsan, Korea, Republic of
Korea University Ansan Hospital
π°π·Gyeonggi-do, Korea, Republic of
National Medical Center
π°π·Seoul, Korea, Republic of
Gangnam Severance Hospital
π°π·Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
π°π·Chungbuk, Korea, Republic of
Kwangju Veterance Hospital
π°π·Kwangju, Korea, Republic of
Yeungnam University Medical Center
π°π·Daegu, Korea, Republic of
Daejeon Eulji Medical Center Eulji University
π°π·Daejeon, Korea, Republic of
Myungji Hospital
π°π·Goyang-si, Korea, Republic of
Chonnam National University Hospital
π°π·Gwangju, Korea, Republic of
Dongguk University Ilsan Hospital
π°π·Ilsan, Korea, Republic of
Inje University Ilsan Paik Hospital
π°π·Ilsan, Korea, Republic of
Inha University Hospital
π°π·Incheon, Korea, Republic of
Kwandong University International St.Mary'S Hospital
π°π·Incheon, Korea, Republic of
Hallym University Medical Center
π°π·Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
π°π·Pusan, Korea, Republic of
Korea University Guro Hospital
π°π·Seoul, Korea, Republic of
Samsung Medical Center
π°π·Seoul, Korea, Republic of
Wonju Severance Christian Hospital
π°π·WΕnju, Korea, Republic of
Hallym University Sacred Heart Hospital
π°π·Anyang-si, Korea, Republic of
Changwon Fatima Hospital
π°π·Changwon, Korea, Republic of
Bundang Jesaeng General Hospital
π°π·Gyeonggi-do, Korea, Republic of
Cha University Bundang Medical Center
π°π·Gyeonggi-do, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
π°π·Gyeonggi-do, Korea, Republic of
Samsung Changwon Hospital
π°π·Gyeongsang, Korea, Republic of
National Health Insurance Service Ilsan Hospital
π°π·Gyeonggi-do, Korea, Republic of
Wonkwang University Hospital
π°π·Iksan, Korea, Republic of
Pusan National University Hospital
π°π·Pusan, Korea, Republic of
Ewha Womans University Mokdong Hospital
π°π·Seoul, Korea, Republic of
Korea University Anam Hospital
π°π·Seoul, Korea, Republic of
Chosun University Hospital
π°π·Gwangju, Korea, Republic of
Kangdong Sacred Heart Hospital
π°π·Seoul, Korea, Republic of
Kyung Hee University Medical Center
π°π·Seoul, Korea, Republic of