NCT00507845已完成4 期
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Mean changes in Systolic Blood Pressure (SBP)
研究概览
简要总结
Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient
- •Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension).
排除标准
- •Already on fixed-dose combination treatment for hypertension
- •Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy
- •Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine.
- •History of angioedema
- •Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
- •Patients with AV block II or III
- •Severely impaired hepatic function.
- •Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
- •Pregnant and lactating mothers
- •Patients on dialysis or haemofiltration.
- •Patients with creatinine clearance < 20ml/min
- •Use of potassium sparing diuretics
- •Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Mean changes in Systolic Blood Pressure (SBP)
时间窗: from baseline to Week 8
次要结局
- Mean changes in Diastolic Blood Pressure (DBP)(from baseline to Week 8)
- Percentage of responders with regard to DBP and SBP(comparison to baseline)
- Adverse events(After treatment and at each follow-up visit)
研究者
研究点 (1)
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