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

Yuhan

Status: Completed

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Study type: Observational

Funder types: Industry

Identifiers

NCT06293261

YMC043

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,047 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

5,047 participants in 4 patient groups

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

Treatment:

Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

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

Treatment:

Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

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

Treatment:

Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Rosuampin 10/10mg (Rosuvastatin

Treatment:

Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg