NCT00335673已完成4 期
Irbesartan in Mild to Moderate Hypertensive 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
- 1,630
- 试验地点
- 1
- 主要终点
- Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.
研究概览
简要总结
- To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
- To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.
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 proved mild to moderate hypertension.
- •Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
- •Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion 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 Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
- •Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
- •Patients with HbA1c > 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 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 blood pressure to target values according to ESC 2003 guidelines at the end of the study.
时间窗: During the study conduct
次要结局
- Occurrence of any side effects leading to treatment discontinuation.(During the study conduct)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular HypertrophyHypertensionNCT00362037Sanofi281
已完成
4 期
I PREVENT - Irbesartan In Hypertensive Diabetic PatientsHypertensionNCT00362258Sanofi797
进行中（未招募）
1 期
Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Irbesartan en el tratamiento del paciente hipertenso con síndrome metabólicoHypertension, nosEUCTR2005-000614-12-ESBristol Myers Squibb International Corporation540
进行中（未招募）
不适用
Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Revised Protocol 2, incorporating Protocol Amendments 01 dated 09-Jan-06 & 02 dated 05-Oct-2006. And Protocol amendment 03 dated 24-Oct-2006 - Biomarkers Substudy.EUCTR2005-000614-12-DEBristol Myers Squibb International Corporation540
进行中（未招募）
不适用
Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Treatment of hypertensive patients with metabolic syndromeMedDRA version: 6.1Level: HLGTClassification code 10057166EUCTR2005-000614-12-ITBRISTOL-M.SQUIBB540