NCT00326768已完成3 期
An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
研究概览
简要总结
The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.
详细描述
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study.
Study Hypothesis:
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.
Comparison(s):
This study has no control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertensive patients who meet the following criteria:
- •In case of using any antihypertensives, mean seated DBP* must be over 90 and under 114 mmHg at Visit 1
- •In case of not using any antihypertensives, mean seated DBP* must be over 95 and under 114 mmHg at Visit 1
- •Mean seated DBP* must be over 90 at Visit 2 (* The mean DBP values will be calculated as the average of three seated measurements taken at two-minute intervals).
- •Age over 20 and under 80 years at Visit 1 (Male or Female)
- •Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
- •Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.
- •1. Patients taking four or more anti-hypertensive medications at Visit 1
- •Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
- •Patients whose mean seated DBP > 114 mmHg and/or mean seated SBP > 200 mmHg at Visit 1, Visit 2 or Visit 3
- •Patients with sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (AV-block II-III, atrial fibrillation etc.)
- •Patients with NYHA functional class heart failure III-IV
- •Patients with a history of myocardial infarction or cardiac surgery within last 6 3 months before signing the informed consent form
- •Patients with a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within last 3 months before signing the informed consent form
- •Patients with a history of unstable angina within last 3 months before signing the informed consent form
- •Patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
- •Patients with a history of stroke or transient ischemic attack within last 6 months before signing the informed consent form
- •Patients with a history of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant
- •Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors
- •Patients with known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulfonamide-derived drugs (e.g. thiazides)
- •Known, suspected or history of gout
排除标准
- 未提供
结局指标
主要结局
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
时间窗: 52 weeks
Incidence of adverse events
时间窗: 52 weeks
Changes in electrocardiogram (ECG)
时间窗: 52 weeks
Changes in blood pressure and pulse rate
时间窗: 52 weeks
次要结局
- Seated blood pressure (BP) normality criteria(after 12 and 52 weeks)
- Changes in seated SBP(after 12 and 52 weeks)
- Seated DBP response rate(after 12 and 52 weeks)
- Seated SBP response rate(after 12 and 52 weeks)
- Changes in seated DBP(after 12 and 52 weeks)
- Seated Diastolic Blood Pressure (DBP) control rate(after 12 and 52 weeks)
- Seated Systolic Blood Pressure (SBP) control rate(after 12 and 52 weeks)
研究者
研究点 (3)
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