NCT02206165Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- The mean change of sitDBP (sitting diastolic blood pressure)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •nean 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
研究组 & 干预措施
Candesartan 8mg + Amlodipine 5mg
Experimental
Candesartan 8mg + Amlodipine 5mg, po, q.d.
干预措施: Candesartan 8mg (Drug)
Amlodipine 5mg
Active Comparator
Amlodipine 5mg, po, q.d.
干预措施: Amlodipine 5mg (Drug)
Candesartan 16mg + Amlodipine 5mg
Experimental
Candesartan 16mg + Amlodipine 5mg, po, q.d.
干预措施: Amlodipine 5mg (Drug)
Candesartan 8mg + Amlodipine 5mg
Experimental
Candesartan 8mg + Amlodipine 5mg, po, q.d.
干预措施: Amlodipine 5mg (Drug)
Candesartan 8mg + Amlodipine 10mg
Experimental
Candesartan 8mg + Amlodipine 10mg, po, q.d.
干预措施: Candesartan 8mg (Drug)
Candesartan 8mg + Amlodipine 10mg
Experimental
Candesartan 8mg + Amlodipine 10mg, po, q.d.
干预措施: Amlodipine 10mg (Drug)
Candesartan 16mg + Amlodipine 5mg
Experimental
Candesartan 16mg + Amlodipine 5mg, po, q.d.
干预措施: Candesartan 16mg (Drug)
Candesartan 16mg + Amlodipine 10mg
Experimental
Candesartan 16mg + Amlodipine 10mg, po, q.d.
干预措施: Candesartan 16mg (Drug)
Candesartan 16mg + Amlodipine 10mg
Experimental
Candesartan 16mg + Amlodipine 10mg, po, q.d.
干预措施: Amlodipine 10mg (Drug)
Candesartan 8mg
Active Comparator
Candesartan 8mg, po, q.d.
干预措施: Candesartan 8mg (Drug)
Candesartan 16mg
Active Comparator
Candesartan 16mg, po, q.d.
干预措施: Candesartan 16mg (Drug)
Amlodipine 10mg
Active Comparator
Amlodipine 10mg, po, q.d.
干预措施: Amlodipine 10mg (Drug)
结局指标
主要结局
The mean change of sitDBP (sitting diastolic blood pressure)
时间窗: From baseline at week 8
次要结局
- Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg(From baseline at week 4 and 8)
- The mean change of sitDBP(From baseline at week 4 and week 8)
- The mean change of sitSBP(From baseline at week 4 and 8)
- Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg(At week 4 and 8)
研究者
研究点 (1)
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