NCT02177487已完成3 期
An Open-Label, Six Month Safety Evaluation of the Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Mild-to-Moderate Hypertension
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
- 100
- 主要终点
- Changes from baseline in 12-lead ECG (electrocardiogram)
研究概览
简要总结
Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients who were randomized and completed all study visits of the preceding double-blind trial with the fixed dose combination (502.261) who meet the following criteria:
- •Patients that are not controlled on telmisartan 80 mg monotherapy at the final visit (Visit 6) of the 502.261 study
- •Patients who are able to provide written informed consent
- •Patients who are able to enter the study immediately upon their completion of the preceding double-blind trial of the fixed dose combination (502.261)
排除标准
- •Patients with any exclusion criterion (except criteria 1, 19 and 20), as defined in the preceding study (502.261):
- •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. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
- •Any women:
- •who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
- •who has a positive urine pregnancy test prior to taking the first dose of open-label medication (at Visit 2)
- •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
- •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 + Hydrochlorothiazide
Experimental
干预措施: Telmisartan/hydrochlorothiazide (Drug)
结局指标
主要结局
Changes from baseline in 12-lead ECG (electrocardiogram)
时间窗: Baseline and month 6
Incidence of adverse events
时间窗: up to 6 months
Changes from baseline in physical examination
时间窗: Baseline and month 6
Changes from baseline in seated blood pressure
时间窗: Baseline, month 1, 3 and 6
Changes from baseline in laboratory tests
时间窗: Baseline and month 6
Changes from baseline in pulse rate
时间窗: Baseline, month 1, 3 and 6
次要结局
未报告次要终点
研究者
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