ITMCTR2000003402尚未招募2 期
Preliminary evaluation of the efficacy and safety of Xuezhikang tablets (LY02404) in the treatment of hyperlipidemia: a multicenter, randomized, double-blind, double-simulation, parallel control of positive drugs, and dose-exploration phase II clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
- 18 至 75（—）
- 性别
- All
入选标准
- •1. Patients with primary hyperlipidemia, refer to the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults (2016 Revision). After the screening period and the diet introduction period, 4.1mmol/L (160mg/dl) <= LDL-C < 5.18 mmol/L (200 mg/dl) and TG <4.5 mmol/L (400 mg/dl);
- •2. 18 <= age <= 75 , male or female;
- •3. Receive dietary control guidance during the trial, and insist on controlling diet and improving lifestyle;
- •4. women of childbearing age (women who had not undergone surgical sterilization or less than 1 year after menopause) had a negative pregnancy test result and were non-lactating women. Male and female subjects of childbearing age agreed to take effective contraceptive measures throughout the study period;
- •5. Must give informed consent to this trial and voluntarily sign a written informed consent, able to maintain good communication with the investigator and abide by the various requirements of the clinical trial (planned visits, laboratory inspections and other trial procedures, etc.).
排除标准
- •1. Homozygous familial hypercholesterolemia
- •2. Dyslipidemia caused by secondary causes, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome , Caused by drugs (such as diuretics, glucocorticoids, etc.);
- •3. Any surgical or medical condition that may seriously affect the absorption, distribution, metabolism, or excretion of the drug: a history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or bowel resection; b current active or recurrent bowel Irritable syndrome (IBS) or inflammatory bowel disease (except those with a history of IBS but asymptomatic at least 6 months before screening visit); c current active gastritis, active ulcer, gastrointestinal bleeding; d pancreatic disease Or a history of gallbladder disease (except for patients with gallbladder disease who had previously undergone cholecystectomy);
- •4. BMI >= 30kg/?;
- •5. History of chronic liver disease or cirrhosis (except those with mild fatty liver as indicated by abdominal color Doppler ultrasound);
- •6. Any of the indicators meet the following criteria: ALT or AST or TBIL > 1.2 ULN; Cr > ULN; CK > ULN;
- •7. Patients with abnormal thyroid function (such as hyperthyroidism, hypothyroidism, etc.) (except those judged by the investigator to have no clinical significance);
- •8. Patients with the following medical history within 6 months prior to the screening visit: acute coronary syndrome (ACS), coronary revascularization, congestive heart failure (New York Heart Association [NYHA] classification > Class II), cerebrovascular accident (including TIA), severe peripheral atherosclerosis, cardiovascular surgery or major surgery, etc.;
- •9. Poorly controlled hypertension, diastolic blood pressure> 100 mmHg and/or systolic blood pressure > 160 mmHg;
- •10. History of myositis, myopathy or rhabdomyolysis, severe muscle abnormalities and neuropathy;
- •11. Diabetes and the condition meets any of the following conditions: Type 1 diabetes, history of diabetic ketoacidosis, uncontrolled type 2 diabetes [defined as glycated hemoglobin (HbA1c) > 7%];
- •12. Use lipid-lowering drugs, such as statins, cholesterol absorption inhibitors, probucol, cholic acid chelating agents, and other cholesterol-lowering drugs (such as Lipbita, Docanol, etc.) within 4 weeks before the screening visit , Fibrates, niacins and high-purity fish oil preparations, microsomal TG transfer protein inhibitors, apolipoprotein B100 synthesis inhibitors, proprotein convertase subtilisin 9 (PCSK9) inhibitors, Chinese medicines with lipid-lowering effect And proprietary Chinese medicines, etc.;
- •13. Those who are intolerant to HMG-CoA reductase inhibitors, have poor efficacy or are ineffective;
- •14. Those who currently use or are expected to need the following drugs or food during the trial: CYP3A4 strong inhibitors (eg ketoconazole, itraconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV Protease inhibitors, popprevir, telarevir, nefazodone, drugs containing compistat), cyclosporine, danazol, diltiazem, verapamil, amiodarone, dronedar Long, coumarin anticoagulant, colchicine, ranolazine, diet pills, grapefruit juice;
- •15. Screening for patients with malignant tumors within 5 years prior to the screening visit, except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma, local prostate cancer after radica
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