NCT00362037已完成4 期
Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
适应症
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
- 281
- 试验地点
- 1
- 主要终点
- Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines
研究概览
简要总结
- To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).
- To emphasize and to evaluate the benefit of Irbesartan in the reduction of left ventricular mass index in hypertensive patients with left ventricular hypertrophy.
- To demonstrate safety of Irbesartan in this population.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proven mild to moderate Hypertension.
- •Patients must have left ventricular mass index > 130g/m2 in men, > 100g/m2 in women, as evidenced by echocardiography before inclusion.
- •Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
- •Patients who were receiving antihypertensive agents (maximum two agents including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.
排除标准
- •Severe hypertension (Systolic BP ≥ 180 mm Hg or Diastolic BP ≥ 110 mm Hg).
- •Patients with left ventricular ejection fraction < 45%.
- •Patients with severe left ventricular hypertrophy.
- •Patients with known secondary hypertension (for another cause other than type 2 Diabetes Mellitus).
- •Diabetic patients with HbA1c > 10%.
- •Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
- •Significant liver disease as shown by SGPT/SGOT (ALT/AST) > 2.5 times the upper limit of the normal range.
- •Currently pregnant or lactating females.
- •Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- •Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
- •Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
- •Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines
时间窗: During the study conduct
Reduction in left ventricular hypertrophy from baseline values to week 36.
时间窗: during the study conduct
次要结局
- Occurrence of any side effect leading to treatment discontinuation.(During all the study conduct)
研究者
研究点 (1)
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