NCT00561964已完成3 期
Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 241
- 主要终点
- Urine albumin excretion rate (UAER)
研究概览
简要总结
To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.
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
- Double (Participant, Investigator)
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
- •Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment > 3 months
- •The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
- •Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be <35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
- •Serum creatinine < 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
- •18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2
排除标准
- •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
干预措施: Irbesartan (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Urine albumin excretion rate (UAER)
时间窗: during the study conduct
次要结局
- SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin(during the study conduct)
研究者
相似试验
已完成
4 期
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With HypertensionHypertensionNCT00529750Sanofi108
已完成
4 期
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes MellitusPROTEINURIAType 2 DiabetesHypertensionNCT00241085Novartis392
已完成
3 期
Irbesartan in Type 2 DiabetesMicroalbuminuriaHypertensionType 2 DiabetesNCT00317915Steno Diabetes Center Copenhagen
已完成
不适用
A study of irbesartan/amlodipine on hypertensive patientsHypertensionJPRN-UMIN000017785Kumamoto University20
已完成
4 期
Irbesartan in HypertensionHypertensionNCT00265967Sanofi88