NCT00362258已完成4 期
Irbesartan In Hypertensive Diabetic Patients
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
- 797
- 试验地点
- 1
- 主要终点
- Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
研究概览
简要总结
- To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
- To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
- To demonstrate the 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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or without microalbuminuria).
- •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 (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
- •Patients with secondary hypertension.
- •Patients with UAE > 200µg / min.
- •Patients with HbA1c < 6% or > 10%.
- •Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
- •Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 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
Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
时间窗: During the study conduct
次要结局
- The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)(During the study conduct)
- First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions)(During the study conduct)
- Occurrence of any side effect leading to treatment discontinuation.(During the study conduct)
研究者
研究点 (1)
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