CORONA: Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rosuampin 10/5mg Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks |
Drug: Rosuampin 10/5mg
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
|
| Experimental: Rosuampin 20/5mg Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
Drug: Rosuampin 20/5mg
Rosuampin 20/5mg qd for 8 weeks
|
| Active Comparator: Amlodipine/Atorvastatin 5/20mg Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
Drug: Amlodipine/Atorvastatin 5/20mg
Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Rate of change from baseline to week 8 in LDL-Cholesterol [Baseline/Week 8]
Secondary Outcome Measures
- Rate of change from baseline to week 4 in LDL-Cholesterol [Baseline/Week 4]
- 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, 8 in glucose index [Baseline/Week 4, 8]
Fasting Blood Glucose, HbA1C, HOMA-IR
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Daegu Catholic Univ. Medical Center | Daegu | Korea, Republic of |
Sponsors and Collaborators
- Yuhan Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YMC040