NCT02651870已完成3 期
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 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
A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 19 or above
- •Inadequately controlled Essential hypertension at Screening
- •Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1
- •Mean sitDBP ≥ 95mmHg on target arm
- •Taking antihypertensive drug but not controlled
- •Mean sitDBP ≥ 90mmHg on target arm
- •Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
- •Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
- •Ability to provide written informed consent
排除标准
- •The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- •Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
- •Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- •Patient with congestive heart failure(NYHA class III, IV)
- •Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
- •History of stroke, cerebral hemorrhage within 6 months
- •Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5%
- •History of severe or malignant retinopathy
- •AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L
- •Patient with acute or chronic inflammatory(treatment required) status
- •Patient who need to take antihypertensive drug besides Investigational products
- •Patient must be treated with medications prohibited for concomitant use during the study period
- •History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- •Hypersensitive to Candesartan/Amlodipine
- •Patient who are dependent on drugs or alcohol within 6 months
- •History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- •Patients treated with other investigational product within 30 days at first time taking the investigational product
- •Women with pregnant, breast-feeding
- •History of malignant tumor within 5 years
- •Not eligible to participate for the study at the discretion of investigator
研究组 & 干预措施
Candesartan 16mg + Amlodipine 5mg
Experimental
Candesartan 16mg + Amlodipine 5mg, po, q.d.
干预措施: Candesartan 16mg (Drug)
Candesartan 16mg + Amlodipine 5mg
Experimental
Candesartan 16mg + Amlodipine 5mg, po, q.d.
干预措施: Amlodipine 5mg (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 16mg
Active Comparator
Candesartan 16mg, po, q.d.
干预措施: Candesartan 16mg (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
- The mean change of sitDBP(From baseline to week 4)
- The mean change of sitSBP(From baseline to week 4 and 8)
- Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg(From baseline to week 8)
- Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg(From baseline to week 8)
研究者
研究点 (1)
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