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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Hypercholesterolemia
• Intervention / Treatment: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

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.

• Study Type: Observational
• Enrollment (Actual): 5047

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang-si, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Changwon, Korea, Republic of
    • Changwon Fatima Hospital
  • Changwon, Korea, Republic of
    • Gyeongsang National University Changwon Hospital
  • Chungbuk, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Chungnam, Korea, Republic of
    • Dankook University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Daejeon Eulji Medical Center Eulji University
  • Goyang-si, Korea, Republic of
    • Myungji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chosun University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Korea University Ansan Hospital
  • Gyeonggi-do, Korea, Republic of
    • Hallym University Dongtan Sacred Heart Hospital
  • Gyeonggi-do, Korea, Republic of
    • CHA University Bundang Medical Center
  • Gyeonggi-do, Korea, Republic of
    • Bundang Jesaeng General Hospital
  • Gyeonggi-do, Korea, Republic of
    • National Health Insurance Service Ilsan Hospital
  • Gyeongsang, Korea, Republic of
    • Samsung Changwon Hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Ilsan, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Ilsan, Korea, Republic of
    • Dongguk University Ilsan Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Kwandong University International St.Mary'S Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Veterance Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • National Medical Center
  • Seoul, Korea, Republic of
    • Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Hallym University Medical Center
  • Seoul, Korea, Republic of
    • Ewha Womans University Seoul Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University
  • Wŏnju, Korea, Republic of
    • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)	Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg; Experimental only, not included active and placebo comparator
Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)	Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg; Experimental only, not included active and placebo comparator
Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)	Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg; Experimental only, not included active and placebo comparator
Rosuampin 10/10mg (Rosuvastatin	Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg; Experimental only, not included active and placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)	Baseline, 12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 hs-CRP	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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Moohyun Kim, Dong-A University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2020
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: long-term efficacy and safety of Rusuampin Tab
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertension; Hypercholesterolemia
• Other Study ID Numbers: YMC043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No