KCT0006283已完成未知
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients with Primary Hypercholesterolemia and Essential Hypertension
Addpharma0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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) < 30 mL/min or eGFR 30 mL/min/1.73 m2.
- •e. Unregulated diabetics whose HbA1c (Hemoglobin A1c) reading is > 9.0%
- •f. Unregulated thyroid dysfunction with TSH (Thyroid Stimulating Hormone)
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6µgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly SubjectsImmunization of healthy people against influenza virus infectionMedDRA version: 14.0Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-003314-16-HUOmninvest Ltd.
进行中（未招募）
不适用
A randomized, double-blind, active-controlled, multicenter study to compare the effect of 24 weeks treatment with a fixed combination therapy of vildagliptin and metformin to the individual monotherapy components in drug naïve patients with type 2 diabetes (T2DM)Type II DiabetesEUCTR2006-002794-51-HUovartis Pharma Services AG1,200
进行中（未招募）
不适用
Study of the safety and efficacy of LCZ696 on arterial stiffness in elderly patients with hypertensioEUCTR2012-002899-14-ESovartis Farmaceutica S.A432
进行中（未招募）
不适用
A randomized, double-blind, active-controlled, multicenter study to compare the effect of 24 weeks treatment with a fixed combination therapy of vildagliptin and metformin to the individual monotherapy components in drug naïve patients with type 2 diabetes (T2DM)EUCTR2006-002794-51-SEovartis Pharma Services AG1,200
进行中（未招募）
不适用
Study of the safety and efficacy of LCZ696 on arterial stiffness in elderly patients with hypertensioEUCTR2012-002899-14-GRovartis Pharma Services AG432