A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 23
- 主要终点
- Change mean sitting Diastolic Blood Pressure (msDBP) 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients greater than or equal to 19 years of age
- •Subject who was diagnosed with essential hypertension or after administer the antihypertensive drug (Subject who may temporarily suspend antihypertensive treatment based on doctor's decision)
- •Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form
排除标准
- •Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
- •Subject with difference of the blood pressure of over 20 mmHg for SBP or 10 mmHg for diastolic blood pressure (DSP) between three consecutive measurements in a selected arm during the screening visit
- •Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- •Symptomatic orthostatic hypotension
- •Severe heart failure( New York Heart Association(NYHA) Class III/IV)
- •Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
- •History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
- •Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c > 9.0%)
- •Subject with Haemodynamic disturbance, heart valve disease with structural defects
- •Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
- •Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
- •Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •Chronic inflammatory disease requiring continuous anti-inflammatory treatment
- •Clinically significant Renal or liver impairment, or laboratory abnormalities such as Ccr: below 30ml/min or Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 x Upper Limit Normal (ULN)
- •Hypokalaemia(Serum potassium < 3.5 mmol/L) or hyperkalaemia(Serum potassium > 5.5 mmol/L)
- •Subject with gastrointestinal disease(such as Crohn's disease, gastric ulcer, acute or chronic pancreatitis) or history of gastrointestinal surgery(not including appendectomy or hernia surgery) that might significantly alter the absorption of the drug
- •history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
- •Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- •Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
- •history of malignant tumors within the past 5 years
- •history of alcohol or drug abuse
- •Pregnant women and lactating mothers
- •Women who is planning to be pregnant during or 2 months after the study, or women or men who are not using medically acceptable methods of contraception *
- •* progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.
- •Use of other investigational products within the past 1 month
- •Subject who are judged by the investigator unsuitable to participate in the study
研究组 & 干预措施
CC 16mg
Candesartan Cilexetil 16mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 16mg (Drug)
Candesartan Cilexetil (CC) 8mg
Candesartan Cilexetil 8mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
Amlodipine(AML) 5mg
Amlodipine 5mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
AML 10mg
Amlodipine 10mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
CC 8mg / AML 5mg
Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
CC 8mg / AML 5mg
Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
CC 8mg / AML 10mg
Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 8mg (Drug)
CC 8mg / AML 10mg
Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
CC 16mg / AML 5mg
Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 16mg (Drug)
CC 16mg / AML 5mg
Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
干预措施: Amlodipine 5mg (Drug)
CC 16mg / AML 10mg
Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
干预措施: Candesartan Cilexetil 16mg (Drug)
CC 16mg / AML 10mg
Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
干预措施: Amlodipine 10mg (Drug)
结局指标
主要结局
Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline
时间窗: Week 8
次要结局
- Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline(Week 4)
- Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline(Week 4 and 8)
- Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg(Week 4 and 8)
- Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg(Week 4 and 8)