NCT00265967已完成4 期
Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug.
研究概览
简要总结
Study objectives:
- To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks
- To evaluate the safety of irbesartan
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having an average value of ≥ 95 mmHg and ≤ 109 mmHg in diastolic blood pressure measurement or an average diastolic blood pressure value of ≥ 85 mmHg in 24-hours arterial blood pressure measurement,
- •Received no treatment within the last 3 months.
排除标准
- •Premenopausal women having at least one of the following conditions,
- •Not surgically sterile,
- •Are nursing,
- •Having childbearing potential and not using a reasonable contraception method or not thinking to continue the method throughout the study. Reasonable contraception methods are: intrauterine device, oral or implantable or injectable contraception methods. No methods other than these are accepted.
- •Patients routinely sleeping within the day since she/he works at nightshift and whose working hours continue in a time shift from midnight to 04:00 A.M.
- •Patients with average systolic blood pressure = 180 mmHg in sitting position or average diastolic blood pressure is ≥110 mmHg in sitting position at baseline visit
- •Having known or suspected secondary hypertension
- •Having renal and/or hepatic failure together with the following laboratory criteria:
- •Having elevated values of SGPT (ALT) or SGOT (ALT) (at least twice the upper limit of normal range)
- •Having serum creatinine levels of > 2.3 mg/dL (or > 203 μmol/L)
- •With bilateral renal artery stenosis or single kidney and unilateral renal artery stenosis or those in post-renal transplantation or with single kidney,
- •Having symptomatic sodium insufficiency, hypokalemia or hyperkalemia,
- •With volume deficiency,
- •With primary hyperaldosteronism,
- •With biliary obstructive disorders,
- •Having congestive heart failure (New York Heart Association (NYHA)-functional class CHF III-IV),
- •With unstable angina pectoris occurring within 3 months before he or she signed the informed consent.
- •With stroke occurring within 6 months before he or she signed the informed consent,
- •With myocardial infarction or having cardiac surgery within three months before he or she signed the informed consent,
- •Underwent PTCA (percutaneous transluminal coronary revascularization) within three months before he or she signed the informed consent,
- •Having continuous tachycardia, atrial fibrillation, atrial flutter or other clinical arrythmias defined by the investigator
- •With hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically related aortic or mitral valve stenosis,
- •With insulin-dependant diabetes mellitus whose blood sugar regulation could not be controlled within the last 3 months after a HbA1C measurement in which it is equal to 10%.
- •With a history of drug or alcohol addiction within the last 6 months before she or he signed the informed consent,
- •Receiving a drug other than those defined in protocol for blood pressure regulation,
- •Who have been participated in any investigational study within the prior month before she or he signed the informed consent
- •With a known hypersensitivity against any drug which will be used.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Irbesartan
干预措施: Irbesartan (Drug)
结局指标
主要结局
Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug.
时间窗: at the end of 6th months to 8th
次要结局
- Diastolic blood pressure measurements recorded in patients' diaries, and during visits.(6-8 weeks)
研究者
研究点 (1)
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