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COMPLETED
NCT07564726
PHASE3

Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol

Sponsor: Celltrion Pharm, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test whether one pill that combines ezetimibe, rosuvastatin, and amlodipine can safely lower cholesterol and blood pressure in Korean adults with high blood pressure and high cholesterol.

Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

163

Start Date

2022-08-05

Completion Date

2024-02-13

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

Amlodipine

Oral tablet containing amlodipine 10 mg administered for 8 weeks.

DRUG

Ezetimibe/Rosuvastatin

Fixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks.

DRUG

Ezetimibe/Rosuvastatin Placebo

Placebo for ezetimibe/rosuvastatin (10mg/20mg)

DRUG

Amlodipine Placebo

Placebo for amlodipine (10mg)

Locations (21)

Korea University Ansan Hospital

Ansan, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Dankook University Hospital

Cheonan, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Yeungnam University Hospital

Daegu, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Cha University Bundang Medical Center

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Severance Hospital

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, South Korea