Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia

NCT ID: NCT06293261

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5047 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-27
• Study Completion Date: 2024-03-31

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.

Conditions

Hypertension; Hypercholesterolemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Intervention Type: DRUG

Experimental only, not included active and placebo comparator

Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Intervention Type: DRUG

Experimental only, not included active and placebo comparator

Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Intervention Type: DRUG

Experimental only, not included active and placebo comparator

Rosuampin 10/10mg (Rosuvastatin

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Intervention Type: DRUG

Experimental only, not included active and placebo comparator

Interventions

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Experimental only, not included active and placebo comparator

Intervention Type: DRUG

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moohyun Kim

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Locations

Hallym University Sacred Heart Hospital

Anyang-si, , South Korea

Dong-A University Hospital

Busan, , South Korea

Changwon Fatima Hospital

Changwon, , South Korea

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Daejeon Eulji Medical Center Eulji University

Daejeon, , South Korea

Myungji Hospital

Goyang-si, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Chosun University Hospital

Gwangju, , South Korea

Bundang Jesaeng General Hospital

Gyeonggi-do, , South Korea

Cha University Bundang Medical Center

Gyeonggi-do, , South Korea

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, , South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

National Health Insurance Service Ilsan Hospital

Gyeonggi-do, , South Korea

Samsung Changwon Hospital

Gyeongsang, , South Korea

Wonkwang University Hospital

Iksan, , South Korea

Dongguk University Ilsan Hospital

Ilsan, , South Korea

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Inha University Hospital

Incheon, , South Korea

Kwandong University International St.Mary'S Hospital

Incheon, , South Korea

Soon Chun Hyang University Hospital Cheonan

Jungbuk, , South Korea

Dankook University Hospital

Jungnam, , South Korea

Kwangju Veterance Hospital

Kwangju, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Pusan National University Yangsan Hospital

Pusan, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Ewha Womans University Seoul Hospital

Seoul, , South Korea

Hallym University Medical Center

Seoul, , South Korea

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Kyung Hee University Medical Center

Seoul, , South Korea

National Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Ulsan University

Ulsan, , South Korea

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

YMC043

Identifier Type: -

Identifier Source: org_study_id