NCT04659070Unknown3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Mean sitting systolic blood pressure (MSSBP)
研究概览
简要总结
This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.
详细描述
The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female aged 19 to 79 years of age
- •a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
- •A person who meets the following criteria at the time of screening (visit 1)
- •MSSBP < 180mmHg and MSDBP < 110mmHg
- •LDL-C ≤ 250 mg/dL and TG < 400 mg/dL (based on organ clinical laboratory testing)
- •A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.
- •Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges)
- •Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking)
- •Patients who have agreed in writing to voluntarily participate in this clinical trial
- •Randomized(Visit 2) criteria
- •If the blood pressure measured at the time of random assignment is as follows:
- •140mmHg ≤ MSSBP < 180mmHg and MSDBP < 110mmHg However, patients with diabetes or chronic neuropathy: 130mmHg ≤ MSSBP < 180mmHg (In the case of chronic neuropathy patients, albuinuria or proteinuria history is confirmed until the time of random assignment.)
- •Therapeutic Lifestyle Change (TLC) after Visit 1 A person whose LDL-C and TG values correspond to the following group-specific criteria (NCEP ATP III guideline) as the basis for organ testing at the time of random assignment.
- •Group1 cardiovascular risk factor : 0~1, LDL-C(mg/dL) : 160-250, TG(mg/dL) : < 400
- •Group2 cardiovascular risk factor : 2 ≤, 10 year risk : < 10% LDL-C(mg/dL) : 160-250 TG(mg/dL) : < 400 cardiovascular risk factor : 2 ≤, 10% ≤ 10 year risk ≤ 20%, LDL-C(mg/dL) : 130-250 TG(mg/dL) : < 400
- •Group3 coronary artery disease or equivalent (20% < 10 year risk), LDL-C(mg/dL) : 100-250 TG(mg/dL) : < 400
- •A person who does not have any inappropriate items when re-checking the selection/excluding criteria at the time of random assignment.
- •(except items that apply only to screening)
排除标准
- •A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
- •Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
- •Standing low blood pressure patient with symptoms
- •Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
- •Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
- •Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized)
- •A person who has one or more of the following forces within the last six months based on a screening visit (visit 1):
- •Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc.
- •Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.)
- •A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs.
- •Patients with gastrointestinal diseases such as active gastritis or duodenal ulcer within one year of screening
- •A person who has a history of muscle toxicity to fibromyalgia, myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and past HMGCoA reducing enzyme inhibitor or fibrate-related drugs.
- •Patients with parathyroidism
- •Patients with shock
- •Patients with biliary obstruction or bile congestion
- •Patients with hereditary vascular edema
- •Patients with a history of vascular edema during ACE inhibitor or Angiotensin II receptor antagonist treatment.
- •Patients with chronic inflammatory diseases who need continuous anti-inflammatory treatment
- •Patients with autoimmune diseases, connective tissue diseases
- •Those who have a history of moderate degree or malignant retinopathy (i.e., retinal bleeding, vision impairment, retinal micro aneurysm) within the previous six months based on a screening visit (visit 1)
- •On the basis of a screening visit (visit 1) a person with malignancy, including leukemia and lymphoma, was evaluated as Complete Response (but not recurrent within at least two years from the screening date, or a malignant tumor that occurred within the minimum two years of the screening, is the only basal cell carcinoma or squamous skin cell carcinoma (Square).
- •Patients who have run out of blood or sodium due to high doses of diuretics, dietary salinity, diarrhea and vomiting.
- •The following institutional clinical laboratory test results (screening criteria) are available:
- •Patients with active liver disease and severe liver disorder (unknown continuous serum AST, elevated or serum ALT, person with AST more than three times the normal upper limit)
- •a person whose CPK (creatine phosphokinase) level is more than twice the normal upper limit.
- •Creatine clearance (CLcr) < 30mL/min or eGFR < 30ml/min/1.73m
- •a person with low potassium haemorrhage (less than 3.5 mmol/L) or high potassium haemorrhage (greater than 5.5 mmol/L)
- •Unregulated diabetics (HbA1c > 9.0%)
- •Unregulated thyroid dysfunction with a TSH level of 1.5 times or more than the normal upper limit
- •In case of the following allergic and hypersensitive history:
- •someone with drug allergy-response anaphylaxis or hepatotoxicity.
- •Angiotensin II receptor blocker family drug or HMG-CoA reducing enzyme inhibitor
- •A person who has overreacted to a clinical trial drug or is hypersensitive to the composition of a clinical trial drug
- •A person who has genetic problems such as galactose intolerance, Lap lactase deficiencies, or glucose-galactose malabsorbtion.
- •A person who is administering a prohibited drug in this clinical trial or is expected to be administered during the clinical trial period.
- •Those who showed a difference of SBP ≥ 20 mmHg and DBP ≥10 mmHg in three consecutive measurements at least two minutes apart on each arm during a screening visit (visit 1)
- •Patients who cannot stop anti-hypertensive drugs or lipid-control drugs that were being administered during a screening visit (visit 1) during the clinical trial period.
- •Those who have or are suspected of drug or alcohol abuse within one year prior to the screening visit (visit 1)
- •Pregnant or breastfeeding women
- •A person who has received another clinical trial medication within three months of the first administration of the clinical trial medication in this clinical trial (if he/she has not administered the clinical trial medication or has participated in non-release observation research, he/she may register).
- •A person who is deemed unfit by the tester (the physician in charge) to participate in this clinical trial
结局指标
主要结局
Mean sitting systolic blood pressure (MSSBP)
时间窗: baseline, week 8
MSSBP change at week 8 compared to baseline, experimental, active comparator1
Low density lipoprotein cholesterol (LDL-C)
时间窗: baseline, week 8
LDL-C change at week 8 compare to baseline, experimental, active comparator2
次要结局
- LDL-C change(baseline, week4, week8)
- Mean sitting systolic blood pressure (MSSBP)(baseline, week 4)
- Mean sitting diastolic blood pressure (MSDBP)(baseline, week 4, week 8)
- Percentage of LDL-C change(baseline, week4)
- the rate of patients who have reached their target blood pressure(week4, week8)
- Achievement rate of LDL-C treatment goals(week4, week8)
- Percentage of lipid indicators change(baseline, week4. week8)
- Lipid indicators chage(basline, week4, week8)
研究者
研究点 (1)
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