NCT00362960已完成3 期
Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 27
- 主要终点
- Efficacy of olmesartan medoxomil doses compared to losartan in
研究概览
简要总结
Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy
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
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female European out-patients
- •Greater than or equal to 30 years of age
- •Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
- •Urinary protein excretion between 200-4000 mg/day exclusive
- •Mean sitting dBP less than or equal to 110 mgHg
- •Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary
排除标准
- •Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
- •Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
- •ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
- •Presence of significant cardiovascular disease
- •Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
- •Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min
- •Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )
- •Serum potassium level < 2.5 mmol/L or > 5.5 mmol/L
- •Treatment of concurrent indications with drugs or medication which could have influenced BP
- •History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)
结局指标
主要结局
Efficacy of olmesartan medoxomil doses compared to losartan in
patients with type 2 diabetes and nephropathy in terms of the change in
proteinuria (total urinary protein excretion) from baseline.
次要结局
- Efficacy of the treatment with olmesartan medoxomil dosages compared to
- losartan in patients with type 2 diabetes and nephropathy in terms of
- change in:
- creatinine clearance (CLCR)
- the protein pattern (nephelometry)
- inflammatory markers (circulating serum markers).
- Evaluate safety and tolerability of all treatments.
研究者
研究点 (27)
Loading locations...
相似试验
已完成
3 期
Olmesartan Medoxomil in Hypertension and Renal ImpairmentEssential HypertensionRenal ImpairmentNCT00151827Sankyo Pharma Gmbh393
已完成
3 期
Olmesartan Medoxomil Versus Losartan in Elderly and Very ElderlyEssential HypertensionNCT00751751Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company441
已完成
不适用
Influence of Olmesartan and azelnidipine on renal function during cardiac surgerymyocardial infarction, angina, aortic dessection, valve diseaseJPRN-UMIN000001637ihon University Itabashi Hospital100
已完成
3 期
Isolated Systolic Hypertension in the Elderly and Very ElderlyIsolated Systolic HypertensionNCT00751829Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company417
已完成
4 期
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With HypertensionHypertensionNCT00185068Daiichi Sankyo110