KCT0002148已完成未知
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Nebivolol/Rosuvastatin combination treatment in patients with concomitant Hypertension and Hyperlipidemia
Elyson Pharmaceutical0 个研究点目标入组 276 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 276
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
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1. Aged between 20 and 79 years
- •2. Signed informed consent
- •3. At screening, Systolic Blood Pressure(SBP)140-179/Diastolic Blood Pressure(DBP)90-109(mmHg), LDL-C ? 250, Triglyceride < 400
- •4. At randomization visit, if the subject is classified by Cardiovascular Risk Factors, the below condition should be complied
- •- Risk factor 0-1: SBP140-179/DBP90-109(mmHg), LDL-C: 160~250, Triglyceride <400
- •- Risk factor?2, 10 year risk<10%: SBP140-179/DBP90-109(mmHg), LDL-C: 160~250, Triglyceride <400
- •- Risk factor?2, 10 year risk = 10 – 20 %: SBP140-179/DBP90-109(mmHg),LDL-C: 130~250, Triglyceride <400
- •- CHD/CHD risk equivalents or 10 year risk>20 %: SBP140-179/DBP90-109(mmHg), LDL-C: 100~250, Triglyceride <400
排除标准
- •1.When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference = 20mmHg or sitDBP difference =10mmHg
- •2. Patients with orthostatic hypotension accompanied symptom
- •3. Patients diagnosed with secondary hypertension or suspected of secondary hypertension by the Investigator (coarctation of aorta, primary aldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing syndrome, etc.).
- •4. Severe heart disease (NYHA class III-IV heart failure), clinically significant valvular disease of the heart, myocardial infarction and unstable angina
- •5. Patients with past history of autoimmune disease uncontrolled by medicine, such as chronic rheumatoid arthritis, systemic lupus erythematosus, etc.
- •6. Patients with past history of bronchospasm or asthma
- •7. Patients with poorly controlled diabetic patients (HemoglobinA1c =9.0%)
- •8. If patients have clinically significant renal or hepatic diseases , or significant hematologic test findings at screening (serum creatinine = 2mg/dL, AST or ALT [aspartate transaminase or alanine transaminase] =2 times of the ULN).
- •9. Surgical or internal disease likely to significantly change absorption, distribution, metabolism, and elimination of drug
- •10. All chronic inflammatory patients requiring chronic inflammatory treatment
- •11. Creatine phosphokinase (CPK) =3 times of the upper limit of normal (ULN).
- •12. Patients with history of malignant tumors including leukemia and lymphoma in the past 5 years
- •13. Patients with past clinical history of alcohol or drug abuse
- •14. Patients with hypersensitivity to investigational product
- •15. Patients who have been administered another investigational product within 30 days prior to participation in this clinical study
- •16. Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study
- •17. Patients who are deemed ineligible as subject in Investigator's judgment for other reasons
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