NCT07564726Befejeződött3. fázis
Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 163 (tényleges)
- Első benyújtás
- 2026. ápr. 27.
- Kezdés
- 2022. aug. 5.
- Elsődleges befejezés
- 2024. febr. 13.
- Fő szponzor
- Celltrion Pharm, Inc.
- Betegségek
- Magas vérnyomás, Familiáris hiperkoleszterinémia
- NCT-szám
- NCT07564726
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Bevont résztvevők: 163
- 2022. aug. 5. és az elsődleges befejezés (2024. febr. 13.) között
- 21 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening
- Retinal hemorrhage, including visual impairment, within 6 months prior to screening
- Patients who received, before study participation, treatment with medications that may affect lipid levels, including bile acid sequestrants, anti-obesity medications, fibrates, niacin, or systemic steroid therapy; however, participation is permitted if the relevant washout period has been completed.
- Need for treatment with protocol-prohibited concomitant medications during the study period
- Use of another investigational product within 4 weeks prior to screening
Más betegség
- History of secondary hypertension or medical history suggestive of secondary hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing disease, pheochromocytoma, or polycystic kidney disease, etc.
- Severe cardiac disease, including congestive heart failure (NYHA class III or IV), clinically significant arrhythmia, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis of the aortic or mitral valve
- Chronic inflammatory disease requiring treatment (e.g., rheumatoid arthritis), or wasting disease, autoimmune disease, or connective tissue disease
- History of myopathy or rhabdomyolysis, or creatine kinase (CK) > 2 times the upper limit of normal
- History of hypersensitivity to ezetimibe, rosuvastatin, amlodipine, or related drug classes
- History of drug or alcohol abuse
- History of malignancy within 5 years before screening, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites, provided that the disease was successfully treated and there has been no recurrence for at least 3 years; enrollment may be considered at the investigator's medical discretion.
- Any other condition or circumstance that, in the investigator's judgment, would make the participant unsuitable for study participation
Laborértékek
- Endocrine or metabolic disease known to affect serum lipids or lipoproteins, including uncontrolled diabetes mellitus (HbA1c > 9%) or uncontrolled thyroid dysfunction (TSH > 1.5 times the upper limit of normal)
- Severe renal or hepatic impairment, defined as AST or ALT > 3 times the upper limit of normal, or serum creatinine > 1.5 times the upper limit of normal
- Patients with gastrointestinal disease or a history of surgery that may affect drug absorption, distribution, metabolism, or excretion, including current active gastritis, gastrointestinal or rectal bleeding, a history of major gastrointestinal surgery, a history of active inflammatory bowel disease within 12 months before screening, or hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Egyéb
- MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening or randomization
- Difference between arms at screening of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
- Symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure of 20 mmHg or more or diastolic blood pressure of 10 mmHg or more on standing compared with sitting or supine blood pressure
- Subjects with secondary dyslipidemia
- Pregnant or breastfeeding participants, or participants unwilling to use appropriate contraception during the study period
A regiszterben nem jelölt feltételek
- 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: LDL-C 160 mg/dL or higher in participants with 1 or fewer major risk factors
- Fasting triglycerides less than 400 mg/dL and LDL-C 250 mg/dL or lower
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (21)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Dél-Korea | Ismeretlen állapot |
| Hallym University Sacred Heart Hospital | Anyang | Dél-Korea | Ismeretlen állapot |
| Kosin University Gospel Hospital | Busan | Dél-Korea | Ismeretlen állapot |
| Pusan National University Hospital | Busan | Dél-Korea | Ismeretlen állapot |
| Dankook University Hospital | Cheonan | Dél-Korea | Ismeretlen állapot |
| Keimyung University - Dongsan Medical Center | Daegu | Dél-Korea | Ismeretlen állapot |
| Daegu Catholic University Medical Center | Daegu | Dél-Korea | Ismeretlen állapot |
| Yeungnam University Hospital | Daegu | Dél-Korea | Ismeretlen állapot |
| Chonnam National University Hospital | Gwangju | Dél-Korea | Ismeretlen állapot |
| Gachon University Gil Medical Center | Incheon | Dél-Korea | Ismeretlen állapot |
| jeonbuk National University Hospital | Jeonju | Dél-Korea | Ismeretlen állapot |
| CHA University Bundang Medical Center | Seongnam | Dél-Korea | Ismeretlen állapot |
| Nowon Eulji Medical Center, Eulji University | Seoul | Dél-Korea | Ismeretlen állapot |
| Korea University Anam Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Kangbuk Samsung Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Asan Medical Center | Seoul | Dél-Korea | Ismeretlen állapot |
| Severance hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Korea University Guro Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Uijeongbu Eulji Medical Center, Eulji University | Uijeongbu-si | Dél-Korea | Ismeretlen állapot |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu-si | Dél-Korea | Ismeretlen állapot |
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