Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure an… (NCT07564726) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
South Korea163 participantsStarted 2022-08-05
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Screening Inclusion Criteria:
* Age 19 years or older at the time of written informed consent
* Diagnosed with essential hypertension and primary hypercholesterolemia, or currently receiving antihypertensive and/or lipid-lowering medication after such diagnosis
* If receiving antihypertensive and/or lipid-lowering therapy at screening, judged by the investigator to be medically appropriate for discontinuation of prior therapy during the clinical trial period
* Able and willing to voluntarily sign the written informed consent form after receiving an explanation of the purpose, methods, and expected effects of the study
Randomization Inclusion Criteria:
* Mean sitting systolic blood pressure (MSSBP) of at least 140 mmHg and less than 180 mmHg, and mean sitting diastolic blood pressure (MSDBP) less than 110 mmHg
* Completion of at least 4 weeks of therapeutic lifestyle modification before administration of the investigational product
* After at least 4 weeks of therapeutic lifestyle modification, fasting LDL-C meeting one of the following criteria:
* Very high-risk group: LDL-C 70 mg/dL or higher in participants with coronary artery disease, atherosclerotic ischemic stroke or transient ischemic attack, or peripheral arterial disease
* High-risk group: LDL-C 100 mg/dL or higher in participants with carotid artery disease, abdominal aneurysm, or diabetes mellitus
* Moderate-risk group: LDL-C 130 mg/dL or higher in participants with 2 or more major risk factors
* Low-risk group:…
What they're measuring
1
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1
Timeframe: Baseline, Week 8
2
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 in Treatment Group and Control Group 2