NCT00141453已完成3 期
CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 577
- 主要终点
- Renal Composite Outcomes
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
- •albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
- •serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men
排除标准
- •type 1 diabetes
- •non-diabetic nephropathy
- •history of myocardial infarction
- •history of cardiac bypass grafting within 3 months
- •history of percutaneous coronary intervention (PCI) within 6 months
- •history of carotid artery or peripheral artery revascularization within 6 months
- •stroke or transient ischemic attack (TIA) within 1 year
- •unstable angina pectoris
- •heart failure of NYHA functional classes III or IV
- •rapid progression of kidney disease within 3 months
- •severe orthostatic hypotension
- •serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
- •history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
- •poor glycemic control: HbA1c level =>11%
- •history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
研究组 & 干预措施
1
Experimental
Olmesartan medoxomil tablets 10mg to 40 mg
干预措施: olmesartan medoxomil (Drug)
2
Placebo Comparator
Matching placebo tablets
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
Renal Composite Outcomes
时间窗: Randomization to 5 years
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
次要结局
- Number of Participants Experiencing Cardiovascular Composite Outcomes(Within 5 years)
- The Change in Proteinuria(Randomization to 5 years)
- Reciprocal (1/Serum Creatinine) of Serum Creatinine(Randomization to 5 years)
研究者
相似试验
已完成
3 期
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established AtherosclerosisAtherosclerosisNCT00382213Daiichi Sankyo210
已完成
3 期
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to OlmesartanHypertensionNCT01876368Novartis Pharmaceuticals376
已完成
3 期
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential HypertensionEssential HypertensionNCT00872586Daiichi Sankyo304
已完成
1 期
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male SubjectsHealthy Male SubjectsNCT02955498Hanlim Pharm. Co., Ltd.32
已完成
3 期
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential HypertensionEssential HypertensionNCT00856271Daiichi Sankyo287