Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin; Rosuvastatin Calcium

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