NCT02059616Unknown2 期
A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection 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
- 384
- 试验地点
- 20
- 主要终点
- Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
研究概览
简要总结
The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 19 and ≤ 75 years old
- •Subject with mild-to-moderate uncomplicated essential hypertension
- •Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial
排除标准
- •Subject with severe hypertension (siDBP ≥ 115 mmHg or siSBP ≥ 185 mmHg)
- •Subject with difference in the mean blood pressure of over 10mmHg for siDBP or 20mmHg for siSBP between both arms at the screening visit
- •Subject with known or suspected secondary hypertension [including but not limited to any of the following: renovascular hypertension, adrenal medullary and cortical hyperfunction, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.]
- •Subject with symptomatic orthostatic hypotension (a sudden fall in siDBP of at least 10 mmHg or siSBP of at least 20 mmHg after standing compared with blood pressure from the sitting or supine position)
- •Subject with Type 1 diabetes mellitus OR Type 2 diabetes mellitus with poor glucose control (defined as subject on insulin treatment, with HbA1c > 9.0%, or with a modification in the oral anti-hyperglycemic medication regiment within the past 12 weeks prior to Visit 1)
- •Subject with severe heart disease (Congestive heart failure (NYHA Class III-IV), ischemic heart disease within the past 6 months (unstable angina, myocardial infarction), peripheral vascular disease, history of Percutaneous Transluminal Coronary Angioplasty or Coronary Artery Bypass Grafting)
- •Subject with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia
- •Subject with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve
- •Subject with severe cerebrovascular disease (history of stroke, cerebral infarction, or cerebral hemorrhage within the past 6 months)
- •Subject with or with a history of wasting disease, autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus), or connective tissue disease
- •Subject with known moderate or malignant retinopathy (history of retinal signs of hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
- •Subject with the following clinically significant laboratory abnormalities:
- •AST or ALT > 3 x Upper Limit Normal (ULN)
- •Serum Creatinine > 1.5 ULN
- •Serum potassium < 3.5 mmol/L or > 5.5 mmol/L
- •Subject with any surgical or medical condition of the gastrointestinal tract that might significantly alter the absorption, distribution, metabolism or excretion of the drug
- •Subject with a history of malignant tumors including leukemia and lymphoma within the past 5 years (except for localized basal cell carcinoma of the skin)
- •Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy
- •Subject with chronic kidney disease on dialysis
- •Subject with cardiogenic shock
- •Subject requiring concomitant use of other antihypertensive or contraindicated drugs during the entire study period
- •Subject with known or suspected contraindications, including history of allergy or hypersensitivity to ARB or dihydropyridine derivatives
- •Subject who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARB
- •Pregnant women, lactating mothers, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception (oral contraceptive, intra-uterine device, condom, etc.), except for women with surgical sterilization. Pre-menopausal women who are not surgically sterilized must have a negative pregnancy test result at Visit 1 and maintain acceptable methods of contraception throughout the study. Periodic abstinence (eg, symptothermal, calendar, post-ovulation methods), or hormonal contraceptive are not acceptable methods of contraception
- •History of drug or alcohol abuse within the past 1 year
- •Use of other investigational products within the past 4 weeks
- •Subject who are judged unsuitable to participate in the study in the opinion of the investigator
研究组 & 干预措施
AML 5mg
Experimental
Amlodipine 5 mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
CC 16mg
Experimental
Candesartan Cilexetil 16 mg, once a day for 8 weeks
干预措施: Candesartan cilexetil 16mg (Drug)
AML 10mg
Experimental
Amlodipine 10 mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
CC 8mg
Experimental
Candesartan Cilexetil 8 mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
AML 5mg/CC 8mg
Experimental
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
AML 5mg/CC 8mg
Experimental
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
AML 5mg/CC16mg
Experimental
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
AML 5mg/CC16mg
Experimental
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
干预措施: Candesartan cilexetil 16mg (Drug)
AML 10mg/CC 8mg
Experimental
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
AML 10mg/CC 8mg
Experimental
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
AML 10mg/CC 16mg
Experimental
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
AML 10mg/CC 16mg
Experimental
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
干预措施: Candesartan cilexetil 16mg (Drug)
结局指标
主要结局
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
时间窗: Week 8
次要结局
- Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8(Week 4 and 8)
- Change in siDBP at week 4(Week 4)
- Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks(Week 8)
- Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks(Week 8)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential HypertensionEssential HypertensionNCT02944734Shin Poong Pharmaceutical Co. Ltd.392
已完成
4 期
Efficacy of Candesartan on Reducing Blood Pressure in Insulin-Resistant, Obese Patients With Hypertension.ObesityHypertensionNCT00775814Takeda188
已完成
2 期
Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and PlaceboObesityHypertensionNCT00282178Umeå University26
已完成
3 期
Efficacy of Candesartan on Symptomatic Heart Failure in Treating Diabetic and Hypertensive Patients.Heart FailureNCT00775840Takeda22
已完成
2 期
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential HypertensionEssential HypertensionNCT00425373Novartis Pharmaceuticals1,474