None listed
Conditions
Interventions
Drug : This clinical trial is a test to evaluate efficacy and safety after eight weeks by comparing AD-2021(Ezetimibe/Atorvastatin) and AD-2022(Amlodipine) combined dose group and each single-dose gro
Sponsors
Addpharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female adults aged 19 or older as of the written consent date 2) A person who has been identified with primary hyper cholesterol and essential hypertension and who can stop existing medications and take clinical trial medications planned for this clinical trial under the judgment of a tester 3) A person who meets the following criteria in a screening test: - MSSBP < 180 mmHg and MSDBP < 110 mmHg - LDL-C = 250 mg/dL and TG < 400 mg/dL 4) A female subject who agrees to maintain the following contraception methods during this clinical trial period or a male person with a female partner who follows under the following conditions: ? Female subjects or female partner of male subjects are menopause (non-therapy-induced menopause of more than 12 months) ? Infertility caused by surgery by female subjects or female partner of male subjects (if ovaries and/or uteruses are not present) ? Patients who agree to absolute abstinence during clinical trials [Intermittent abstinence (e.g. by ovulation period, symptothermal method, or progestational stage) or coitus interruptus in the case of female subjects do not applicable to agreement of asceticism.] ? Patients who agree to use the following contraception methods during clinical trials if the female subject or female partner of a male subject is a childbearing woman (WOCBP) who has not undergone sterilization. a. Both female subject and female partner of the male subject: intrauterine device/tubal ligation and fertility surgery/combination use of condom or diaphragm and spermicide b. Male subjects (male partners of female subjects are not applicable): condoms [Note: The use of oral hormone contraceptive pill and hormone contraceptive pill for intradermal implantation does not correspond to the contraceptives accepted in this clinical trial. However, the use of oral hormone contraceptive pill by male subjects' spouses or sex partners is permitted] 5) Patients who voluntarily agree to participate in this clinical trial
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are excluded from clinical trials: 1) Disorders to be excluded a. A person suspected of secondary hypertension or secondary hypertension - Coarctation of aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing syndrome, polycystic kidney disease, etc. b. Secondary dyslipidemia patients - nephrotic syndrome, dysproteinemia, obstructive pulmonary disease, Cushing syndrome, etc. c. A orthostatic hypotension patient with symptoms d. Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia patients that the tester has determined to be clinically meaningful. e. Patients who have hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, severe aortic stenosis, coarctation of the aorta, hemodynamically meaningful aortic or mitral stenosis f. Patients with severe heart failure (NYHA class III and IV) g. Those who have one or more of the following in the last six months as of the date of the screening visit: - Those who have received ischemic heart disease (unstable angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, etc. - Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, transient ischemic attack, etc.) 2) Past medical history and accompanying diseases a. A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that may affect the absorption, distribution, metabolism, and excretion of drugs. b. Fibromyalgia, Myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and history of muscle toxicity to past HMG-CoA reductase inhibitors or fibrates-based drugs. c. Shock patients d. Patients with biliary atresia or cholestasis e. Patients with chronic inflammatory diseases requiring continuous anti-inflammatory treatment f. Patients with consumption diseases, autoimmune diseases, and connective tissue diseases g. Patients with gastrointestinal diseases, such as active stomachs or duodenal ulcers, within a year before the screening. h. A person who has a history of moderate degree or malignant retinopathy (retinal bleeding, vision impairment, retinal microaneurysm) within the previous six months from the time of screening. i. Any person with malignant tumor containing leukemia and lymphoma within five years before the screening. (However, those who have been assessed as Complete Response and have not had a recurrence within at least two years from the time of screening, or whose malignant tumor is the only basal cell carcinoma or squamous cell carcinoma of the skin, may be registered.) 3) Results of clinical laboratory tests a. Patients with active liver disease and severe liver disorder (unknown continuous rise of serum AST and ALT or person with serum ALT and AST more than twice the normal upper limit) b. A person whose CK (Creatine kinase) level is more than twice the normal upper limit; c. A person whose SCr (serum creatine) level is 1.5 times or more than the normal upper limit. d. For CLr (Creatinine Clearance) 9.0% f. Unregulated thyroid dysfunction with TSH (Thyroid Stimulating Hormone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in LDL-C in test group and control group 2 at 8 weeks of administration of investigational products to the base;Amount of change in MSSBP in test group and control group 1 at 8 weeks of administration of investigational products to the base | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in MSSBP in test group and control group 1 or test group and control group 2 at 4 weeks to the base;Rate of change in LDL-C in test group and control group 1 or test group and control group 2 at 4 weeks to the base;Amount of change in MSDBP in test group and control group 1 or test group and control group 2 at four weeks and eight weeks to the base;The proportion of patient who has reached a treatment goal of blood pressure in test group and control group 1 or test group and control group 2 at four weeks and eight weeks after administering investigational products;Rate of LDL-C treatment goal achievement based on 2016 ESC/EAS guideline criteria in test group and control group 1 or test group and control group 2 at four weeks and eight weeks after administering investigational products;Rate of change in TC, rate of change in HDL-C, rate of change in TG, rate of change in LDL-C/HDL-C, rate of change in non-HDL-C, rate of change in Apolipoprotein B in test group and control group 1 or test group and control group 2 at four weeks and eight weeks after administering investigational products to the base | — |
Countries
Korea, Republic of
Contacts
Public ContactHanna Jung
Addpharma
Outcome results
None listed