Dyslipidemias, Hypertension
Conditions
Brief summary
This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
Interventions
DRUGRosuampin 20/5mg
Rosuampin 20/5mg qd for 8 weeks
DRUGAmlodipine/Atorvastatin 5/20mg
Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
DRUGRosuampin 10/5mg
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both man and woman who is over 19 years old * Patient with dyslipidemia and hypertension * Written informed consent
Exclusion criteria
* Triglyceride ≥ 400 mg/dL at screening * Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors * sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg * A history of rhabdomyolysis, myopathy * Patient with hypersensitivity to Statin or Amlodipine * Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening * AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease * Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range) * Contraindications stated in the Label of Rosuampin or Caduet * Those participating in other clinical trials for investigational products at screening * Patients deemed to be ineligible to participate in the trial by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change from baseline to week 8 in LDL-Cholesterol | Baseline/Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who reached the therapeutic goal to week 8 | Week 8 | \* Group I: \< 160 mg/dL, Group II: \< 130 mg/dL, Group III: \< 100 mg/dL |
| Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C) | Baseline/Week 4, 8 | Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a) |
| Rate of change from baseline to week 4, 8 in hs-CRP | Baseline/Week 4, 8 | — |
| Rate of change from baseline to week 4 in LDL-Cholesterol | Baseline/Week 4 | — |
| Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm | Baseline/Week 4, 8 | — |
| Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm | Baseline/Week 4, 8 | — |
| The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) | Week 8 | — |
| Rate of change from baseline to week 4, 8 in glucose index | Baseline/Week 4, 8 | Fasting Blood Glucose, HbA1C, HOMA-IR |
Countries
South Korea
Outcome results
None listed