IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Blood pressure at the end of each 4 week treatment period
研究概览
简要总结
The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.
These factors can be of different types:
- Environmental factors (sodium or alcohol intake);
- Morphological (height, weight, body mass index, body surface area);
- Initial blood pressure;
- Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
- Biological parameters as the activity level of the renin angiotensin aldosterone system;
- Genetic polymorphisms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants have to be 25 to 60 years of age
- •Both genders
- •Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.
- •Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.
排除标准
- 未提供
研究组 & 干预措施
Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Perindopril (T1) (Drug)
Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Indapamide (T2) (Drug)
Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Perindopril (T1) (Drug)
Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Perindopril (P1) (Drug)
Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Indapamide (P2) (Drug)
Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Indapamide (T2) (Drug)
Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Perindopril (T1) (Drug)
Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Perindopril (P1) (Drug)
Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Indapamide (P2) (Drug)
Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Indapamide (T2) (Drug)
Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Perindopril (P1) (Drug)
Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Indapamide (P2) (Drug)
Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Indapamide (T2) (Drug)
Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Perindopril (T1) (Drug)
Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Perindopril (P1) (Drug)
Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
干预措施: Placebo of Indapamide (P2) (Drug)
结局指标
主要结局
Blood pressure at the end of each 4 week treatment period
时间窗: 16 weeks
Change from baseline and after each 4 week treatment period
次要结局
未报告次要终点