Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Blood pressure control
研究概览
简要总结
The aim of this study is to compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with uncontrolled arterial hypertension (the average 24h blood pressure in the range 130/80 - 180/110 mmHg and / or daytime average blood pressure in the range 135/85-180/110 mmHg) and one of the following:
- •a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l
- •a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l
- •Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin
排除标准
- •hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins
- •angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors)
- •severe hypotension, shock, including cardiogenic shock
- •hemodynamically unstable heart failure
- •Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal
- •Women of childbearing age without reliable contraception
- •breastfeeding
- •Patients with contraindications listed in the currently valid SP
研究组 & 干预措施
Free combination
Free combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks free combination will be changed to fixed combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study.
干预措施: Atorvastatin, Amlodipine, Perindopril (Drug)
Fixed combination
Fixed combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks fixed combination will be changed to free combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study.
干预措施: Atorvastatin, Amlodipine, Perindopril (Drug)
结局指标
主要结局
Blood pressure control
时间窗: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h and in clinic blood pressure over the 16 weeks follow up.
Lipids control
时间窗: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up.
次要结局
- Adherence(16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine)
- Blood pressure variability(16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine)
- Arterial properties(16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine)
研究者
Peter Wohlfahrt
Peter Wohlfahrt, MD, PhD
Charles University, Czech Republic