Hypercholesterolemia, Hypertension
Conditions
Keywords
long-term efficacy and safety of Rusuampin Tab
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.
Interventions
DRUGRosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator
Sponsors
Yuhan Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) | Baseline, 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed