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

Launched by YUHAN CORPORATION · May 13, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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