KCT0004273招募中未知
A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 304
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 o Limit（—）
- 性别
- All
入选标准
- •1) A person who has good TLC performance during the clinical trial
- •2) Those who meet the following criteria for hypertension and dyslipidemia during the baseline visit
- •- 145 mmHg = mean systolic blood pressure (msSBP) <190 mmHg
- •- Triglycerides <500 mg / dL
- •LDL-C = 250 mg / dL
- •However, the following LDL-C values ??must be met according to risk group classification.
- •1. Low risk: Major risk factors 1) Less than 1 (LDL-C (mg / dL) = 160)
- •2. Moderate-risk group: Major risk factors 1) Two or more (LDL-C (mg / dL) = 130)
- •3. High-risk group (LDL-C (mg / dL) = 100)
- •Carotid disease 2)
- •Abdominal aneurysm diabetes 3)
- •4. Very high risk (LDL-C (mg / dL) = 70)
- •Coronary artery disease
- •Atherosclerotic ischemic stroke and transient ischemic attack
- •Peripheral vascular disease
- •1) age (male =45 years, female =55 years), family history of early onset coronary artery disease, hypertension, smoking, low HDL cholesterol
- •2) Carotid stenosis is confirmed
- •3) If the target has major risk factors for organ damage or cardiovascular disease, the target can be adjusted downward according to the patient.
排除标准
- •1) The blood pressure difference of selected arm at the screening was systolic blood pressure (sSBP) = 20 mmHg and systolic blood pressure (sDBP) =10 mmHg
- •2) Patients with symptomatic orthostatic hypotension and those with secondary or dyslipidemia
- •3) Those who have confirmed the following history or surgery /
- •(1) unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebrovascular disease (stroke, cerebral infarction, cerebral hemorrhage) within 3 months from the screening point,
- •(2) Severe eye-related disorders (retinal hemorrhage within 6 months from screening, visual disturbance, retinal microaneurysm, etc.)
- •(3) Patients with a history of angioedema when treated with genetic angioedema or similar agents (angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist)
- •(4) rhabdomyolysis, myopathy,
- •(5) autoimmune diseases that require continuous treatment (such as rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •(6) Those who have been diagnosed with alcohol or substance abuse
- •(7) Significant mental illnesses (such as depression, depression, bipolar disorder, etc.)
- •(8) Malignant tumor within 5 years before the clinical trial
- •4) Those accompanying the following accompanying diseases and hematological laboratory tests abnormalities
- •(1) Severe aortic stenosis
- •(2) biliary obstruction or cholestasis
- •(3) Diseases causing secondary hypertension (coarctation of the aorta, hyperaldosteronemia, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
- •(4) Unregulated thyroid dysfunction (TSH = 1.5x upper normal level of the organ (ULN))
- •(5) Unadjusted diabetes (HbA1c =9%)
- •(6) Severe heart failure (NYHA class III / IV)
- •(7) Moderate or abnormal renal function (CLcr <30 mL / min / 1.73 m2)
- •(8) AST or ALT & gt; = 2xULN
- •(9) CK & gt; = 2xULN
- •(10) Hyperkalemia (K> 5.5 mEq / L)
- •(11) Uncalibrated sodium depletion or fluids depletion
- •(12) Known HIV virus infected person
- •5) Patients with a history of gastrointestinal surgery (except for simple cecal surgery or hernia surgery) accompanied by gastrointestinal diseases (Crohn's disease, acute or chronic pancreatitis, etc.) that may affect the absorption of pharmaceuticals for clinical trials
- •6) Those who are expected to take / take the following drugs / foods during the clinical trial including screening
- •(1) Drugs for clinical trials Other antihypertensive agents and antihyperlipidemic agents (lipid regulators)
- •(2) Drugs or foods that can affect blood pressure / blood lipids
- •- systemic corticosteroids, lipolytic enzyme inhibitors, vasoconstrictors, nonsteroidal anti-inflammatory analgesics (provided that the duration of continuous administration is 7 days or less during the test period and not within 4 days from the date of visit, 100 mg / day or less Aspirin and topical medications), hormone replacement therapy / thyroid medication (provided that stable doses are available for at least 12 weeks prior to screening and no dose changes are expected during the trial)
- •(3) Drugs known to have drug interaction with other clinical trial drugs
- •7) Drugs or ingredients for clinical trials or hypersensitivity to the corresponding series
- •8) Pregnant or lactating women and appropriate contraception a.
- •a) Infertility procedures (vasectomy, tubal ligation, etc.), double blockage (use in combination with saline and condom / spermicide and vaginal septum, vaginal sponge or neck cap)
- •9) If the subject is administered a
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