NCT00171067已完成3 期
A Study to Evaluate the Effectiveness of Valsartan 320 mg in Combination With Lisinopril 20 mg Versus Monotherapy With Lisinopril 40 mg or Valsartan 320 mg in Hypertensive Patients With Microalbuminuria on the Reduction of Urinary Albumin Creatinine Ratio
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Change from baseline in urinary albumin excretion after 30 weeks
研究概览
简要总结
The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate hypertension with a mean sitting diastolic blood pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until < 2 days prior to Visit 1
- •Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
- •Confirmation of MAU of at least 2 out of 3 measurements determined in the first morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day -7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5 mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0 mg/mmol at both visits.
排除标准
- •Evidence of renal impairment as determined by any one of the following:
- •serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault formula [Cockroft and Gault, 1976] and/or
- •serum creatinine > 1.25 x ULN at Visit 1,
- •a history of dialysis, or
- •a history of nephrotic syndrome.
- •Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- •Any medical condition which might significantly alter the urinary excretion of albumin
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in urinary albumin excretion after 30 weeks
次要结局
- Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg
- Change from baseline in blood test for kidney function after 30 weeks
- Change from baseline in circulating marker of inflammation after 30 weeks
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan AloneHypertensionNCT00170989Novartis2,714
已完成
2 期
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential HypertensionEssential HypertensionNCT00425373Novartis Pharmaceuticals1,474
已完成
3 期
Efficacy and Safety of Valsartan and the Combination of Valsartan and SimvastatinHypertensionHypercholesterolemiaDyslipidemiaNCT00385931Novartis412
已完成
3 期
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 MgHypertensionNCT00241137Novartis3,790
已完成
3 期
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term HemodialysisHypertensionNCT00171080Novartis86