NCT02738632已完成3 期
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients Not Controlled by Telmisartan/Amlodipine Combination
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
- 300
- 试验地点
- 1
- 主要终点
- The change of sitting systolic blood pressure
研究概览
简要总结
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination
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
- •19 years old or above Koreans living in Korea
- •Patients with uncontrolled essential hypertension at screening time(Visit 1)
- •Naïve: 160 mmHg ≤ sitSBP < 200 mmHg
- •Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
- •Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)
- •140 mmHg ≤ sitSBP < 200 mmHg
- •Patients who agreed to participate in the trial
排除标准
- •Test results showing the following values at screening time(Visit 1)
- •The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement
- •screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg
- •Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
- •Patients with congestive heart failure(NYHA class III~IV)
- •Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry
- •Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
- •Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
- •Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
- •Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
- •Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT > 2.5 times of upper limit of normal range)
- •Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators)
- •Patients who should be administered medications prohibited for concomitant use during study period
- •Patients who are dependent on drugs or alcohol
- •Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion
- •Patients with hypersensitivity to the components of investigational drug.
- •Patients with hypersensitivity to Sulfonamide
- •Patients with anuria
- •Patients with hypercalcemia, hyponatremia/hypokalemia
- •Patients with Addison's disease
- •Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy
- •History of malignant tumor including leukemia, lymphoma within 5 years
- •Patients taking other clinical trial drugs within 30 days from the time of visit for screening
- •Pregnancy, breast-feeding, or child-bearing potential Patients
- •Patients who are judged unsuitable to participate in this study by investigator
研究组 & 干预措施
Telmisartan/Amlodipine+Hydrochlorothiazide
Experimental
Telmisartan/Amlodipine combination drug and Hydrochlorothiazide
干预措施: Telmisartan/Amlodipine+Hydrochlorothiazide (Drug)
Telmisartan/Amlodipine
Active Comparator
Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide
干预措施: Telmisartan/Amlodipine (Drug)
Telmisartan/Amlodipine
Active Comparator
Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide
干预措施: Placebo for Hydrochlorothiazide (Drug)
结局指标
主要结局
The change of sitting systolic blood pressure
时间窗: From baseline at week 8
次要结局
- The ratio of subjects who get normalized blood pressure(at week 2 and 8)
- The change of sitting systolic blood pressure(From baseline at week 2)
- The change of sitting diastolic blood pressure(From baseline at week 2 and 8)
- Response Rate(at week 2 and 8)
研究者
研究点 (1)
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