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

Hypertension Clinical Trial

— CORONA  

Official title:

Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951207
• Other study ID #: YMC040
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2019
• Est. completion date: September 29, 2021

Study information

• Verified date: December 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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, ß-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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• Rosuampin 10/5mg
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
• Rosuampin 20/5mg
Rosuampin 20/5mg qd for 8 weeks
• Amlodipine/Atorvastatin 5/20mg
Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic Univ. Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change from baseline to week 8 in LDL-Cholesterol		Baseline/Week 8
Secondary	Rate of change from baseline to week 4 in LDL-Cholesterol		Baseline/Week 4
Secondary	Proportion of subjects who reached the therapeutic goal to week 8	* Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL	Week 8
Secondary	Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)	Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a)	Baseline/Week 4, 8
Secondary	Rate of change from baseline to week 4, 8 in hs-CRP		Baseline/Week 4, 8
Secondary	Rate of change from baseline to week 4, 8 in glucose index	Fasting Blood Glucose, HbA1C, HOMA-IR	Baseline/Week 4, 8
Secondary	Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm		Baseline/Week 4, 8
Secondary	Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm		Baseline/Week 4, 8
Secondary	The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)		Week 8