Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia (CORONA)

Yuhan

Status and phase: Completed; Phase 4

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: Amlodipine/Atorvastatin 5/20mg; Drug: Rosuampin 20/5mg; Drug: Rosuampin 10/5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03951207

YMC040

Details and patient eligibility

About

This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia

Enrollment: 259 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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259 participants in 3 patient groups

Rosuampin 10/5mg

Experimental group

Description:

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Treatment:

Drug: Rosuampin 10/5mg

Rosuampin 20/5mg

Experimental group

Description:

Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Treatment:

Drug: Rosuampin 20/5mg

Amlodipine/Atorvastatin 5/20mg

Active Comparator group

Description:

Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Treatment:

Drug: Amlodipine/Atorvastatin 5/20mg