KCT0001846已完成未知
A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients with Essential Hypertension
Chong Kun Dang0 个研究点目标入组 456 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
- 456
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(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Age of 18 or above
- •Essential hypertension with 90mmHg = mean sitDBP = 115mmHg on target arm at Visit 3
- •Ability to provide written informed consent
排除标准
- •Mean sitDBP = 116mmHg or mean sitSBP = 200mmHg at Visit 1, Visit 2, Visit 3
- •The change of mean sitDBP = 10mmHg or mean sitSBP = 20mmHg on target arm at Visit 1
- •Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- •Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
- •History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- •Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
- •History of severe or malignant retinopathy
- •AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
- •Patients with acute or chronic inflammatory status, autoimmune disease
- •Patients who need to take antihypertensive drug besides Investigational products
- •Patients must be treated with medications prohibited for concomitant use during study period
- •Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
- •Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- •History of malignant tumor within 5 years
- •Patients who are dependent on drugs or alcohol
- •History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- •Patients treated with other investigational product within 4 weeks at the time concents are obtained
- •Women with pregnant, breast-feeding
- •Not eligible to participate for study at the discretion of investigator
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