A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 885
- 试验地点
- 195
- 主要终点
- Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
研究概览
简要总结
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.
The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.
详细描述
This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy.
After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment.
Study Hypothesis:
Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses:
Null Hypothesis:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Aged 30-70 years of age
- •Hypertension at screening defined as:
- •an average cuff systolic blood pressure > 130 mmHg and/or diastolic blood pressure >80 mmHg in untreated patients OR
- •patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension)
- •Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)
排除标准
- 未提供
结局指标
主要结局
Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
时间窗: Baseline, after 1 year of treatment
次要结局
- Change from baseline in 24-hour urinary albumin excretion rate (UAER).(Baseline, after 1 year of treatment)
- Change from baseline in 24-hour urinary sodium excretion rate.(Baseline, after 1 year of treatment)
- Change from baseline in estimated glomerular filtration rate (eGFR).(Baseline, after 1 year of treatment)
- Time to a composite of a doubling of serum creatinine concentration , end-stage renal disease (ESRD), or all cause death(after 1 year of treatment)
- Time to a composite of morbidity and mortality from cardiovascular causes (myocardial infarction (MI), stroke, first hospitalisation for heart failure or unstable angina, coronary or peripheral revascularisation).(after 1 year of treatment)
- Change from baseline in plasma adiponectin levels.(Baseline, after 1 year of treatment)
- Change from baseline in serum creatinine.(Baseline, after 1 year of treatment)
- Change from baseline in urine 8-iso-prostaglandin F2α levels(Baseline, after 1 year of treatment)
- Change from baseline in serum high sensitive C-reactive protein (CRP) levels.(Baseline, after 1 year of treatment)
- Change from baseline in creatinine clearance(Baseline, after 1 year of treatment)
- Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels.(Baseline, after 1 year of treatment)
- Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index).(Baseline, after 1 year of treatment)
- Change from baseline in BP endpoints (SBP, DBP and pulse pressure)(Baseline, after 1 year of treatment)