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

Completed

• Conditions: Hypertension; Hypercholesterolemia
• 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.

Study Timeline

• Study Start: 2020-06-27
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-05
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5047

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 & 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 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

Trial Locations

Locations (39)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-si, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Changwon Fatima Hospital; 🇰🇷 Changwon, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Chungbuk, Korea, Republic of

Dankook University Hospital; 🇰🇷 Chungnam, 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; 🇰🇷 Daegu, Korea, Republic of

Daejeon Eulji Medical Center Eulji University; 🇰🇷 Daejeon, Korea, Republic of

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