NCT00564187已完成4 期
Prospective, Multicentric, Randomized, Open, Comparative Phase IV Study Evaluating the Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
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
- 115
- 试验地点
- 1
- 主要终点
- To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks)
研究概览
简要总结
Primary:
- To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks)
Secondary:
- To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks
- To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks
- To evaluate rate of adverse events during the study
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
- 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
- •Mild to Moderate hypertension (90mmHg<DBP<110mmHg and 140mmHg<SBP<180mmHg)
- •Or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet
- •Or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion
- •A minimum exam labs as required by WHO-ISH within the month before the inclusion
排除标准
- •Severe Arterial Hypertension (PAS > than or = to 180 mm Hg or PAD > than or = to 110 mmHg)
- •Isolated Systolic Hypertension
- •Secondary Hypertension
- •Bilateral renal arterial stenosis or renal arterial stenosis
- •Non surgically sterilised woman or non post-menopausal woman
- •Confirmed sodium depletion
- •Irbesartan hypersensitivity
- •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
Active Comparator
Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
• 150mg/day for normalized patients and patients responding non normalized randomized in the group A
干预措施: Irbesartan (Drug)
2
Active Comparator
• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B
干预措施: Irbesartan (Drug)
结局指标
主要结局
To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks)
时间窗: at 6 weeks of treatment
次要结局
- • To evaluate the percentage of patients with DBP<90 mmHg(at 6 and 12 weeks)
- • To evaluate rate of adverse events(during the study duration)
- • To evaluate the percentage of patients with SBP<140 mmHg(at 6 and 12 weeks)
研究者
研究点 (1)
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