NCT00939588已完成2 期
An 8 Week, Double-blind, Randomized, Parallel-group Study to Compare the Effect of Aliskiren 300mg + Valsartan 320mg vs. Telmisartan 80mg + Ramipril 10mg on Biomarkers of the Renin-angiotensin-aldosterone System in Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone
研究概览
简要总结
This study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females of non-childbearing potential, 18 to 65 years of age with moderate hypertension
- •Patients who are eligible and able to participate in the study
- •Exclusion criteria:
- •Severe hypertension or secondary form of hypertension.
- •Serum potassium > 5.1 mEq/L (mmol/L)
- •Heart failure
- •Any history of hypertensive encephalopathy or cerebrovascular accident; any history of TIA, myocardial infarction, coronary bypass surgery or percutaneous coronary intervention
- •Uncontrolled or life-threatening arrythmia
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Aliskiren and Valsartan
Experimental
干预措施: Aliskiren/ Valsartan (Drug)
Telmisartan and Ramipril
Active Comparator
干预措施: Telmisartan/ Ramipril (Drug)
结局指标
主要结局
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone
时间窗: 56 days
次要结局
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II(56 days)
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure(56 days)
- Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan(56 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)Osteoporosis, PostmenopausalNCT00092040Organon and Co936
已完成
4 期
A Study Evaluating Duloxetine in Patients Hospitalized for Severe DepressionMajor Depressive DisorderNCT00422162Eli Lilly and Company339
已完成
3 期
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes MellitusDiabetic Macular EdemaNCT01171976Novartis Pharmaceuticals373
已完成
不适用
A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.Dentin SensitivityNCT02651467GlaxoSmithKline221
进行中（未招募）
不适用
An Efficacy Trial in the Research Area of Gastrointestinal Health & BloatingGastrointestinal DysfunctionNCT05418127Coconut Goodness Food Products Inc.60