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

Phase 4

Completed

• Conditions: Dyslipidemias; Hypertension
• Interventions: Drug: Amlodipine/Atorvastatin 5/20mg; Drug: Rosuampin 20/5mg; Drug: Rosuampin 10/5mg

• Registration Number: NCT03951207
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-05-30
• Status Verified: 2020-12
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

• Both man and woman who is over 19 years old
• Patient with dyslipidemia and hypertension
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine/Atorvastatin 5/20mg	Amlodipine/Atorvastatin 5/20mg	Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks
Rosuampin 20/5mg	Rosuampin 20/5mg	Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks
Rosuampin 10/5mg	Rosuampin 10/5mg	Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Primary Outcome Measures

Name	Time	Method
Rate of change from baseline to week 8 in LDL-Cholesterol	Baseline/Week 8

Secondary Outcome Measures

Name	Time	Method
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 msSBP & msDBP in both arm	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
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)	Week 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 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 difference of msSBP & msDBP in both arm	Baseline/Week 4, 8

Trial Locations

Locations (1)

Daegu Catholic Univ. Medical Center; 🇰🇷 Daegu, Korea, Republic of