NCT02177435已完成3 期
An Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 491
- 主要终点
- Change from baseline in seated diastolic blood pressure (DBP) at trough
研究概览
简要总结
Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks of treatment.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of mild-to-moderate hypertension
- •Patients who fail to respond adequately to telmisartan monotherapy
- •Participants between 18 and 80 years of age
- •Ability to provide written informed consent
排除标准
- •Patients taking more than three anti-hypertensive medications at the screening visit
- •Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening)
- •Who are not surgically sterile (hysterectomy, tubal ligation)
- •Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study
- •Any women:
- •Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
- •Who is nursing
- •Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- •SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
- •Serum creatinine > 2.3 mg/dL
- •Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
- •Known or suspected secondary hypertension
- •Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
- •Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
- •Unstable angina within the past three months
- •Stroke within the past six months
- •Myocardial infarction or cardiac surgery within the past three months
- •PTCA (percutaneous transluminal coronary angioplasty) within the past three months
- •History of angioedema
- •Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
- •Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- •Administration of digoxin or other digitalis-type drugs
- •Patients with insulin treated Type II diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
- •Known drug or alcohol dependency within the past one year period
- •Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
- •Patients receiving any investigational therapy within one month of signing the informed consent form. Patients who have participated in previous telmisartan studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
- •Known hypersensitivity to any component of the formulations
- •Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of trial medication
研究组 & 干预措施
Telmisartan
Experimental
干预措施: Placebo (Drug)
Telmisartan plus Hydrochlorothiazide
Experimental
干预措施: Telmisartan/Hydrochlorothiazide (Drug)
Telmisartan plus Hydrochlorothiazide
Experimental
干预措施: Placebo (Drug)
Telmisartan
Experimental
干预措施: Telmisartan (Drug)
结局指标
主要结局
Change from baseline in seated diastolic blood pressure (DBP) at trough
时间窗: Baseline (day 0), day 28, day 56
次要结局
- Change from baseline in seated systolic blood pressure (SBP) at trough(Baseline (day 0), day 28, day 56)
- Change from baseline in standing DBP and SBP at trough(Baseline (day 0), day 28, day 56)
- Blood pressure control (seated DBP < 90 mmHg)(16 weeks)
- Systolic blood pressure response(16 weeks)
- Number of patients with abnormal findings in physical examination(Baseline (screening), day 0 and day 56)
- Changes from baseline in heart rate(Baseline (screening), day -56, -28, 0, 28 and 56)
- Number of patients with abnormal changes in laboratory parameters(Baseline (screening), day 0 and day 56)
- Number of patients with abnormal changes in resting 12-lead ECG (electrocardiogram)(Baseline (screening), day 0 and day 56)
- Orthostatic changes in blood pressure(Baseline (screening), day -56, -28, 0, 28 and 56)
- Number of patients with adverse events(up to 16 weeks)
研究者
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