EUCTR2012-001658-24-BG进行中（未招募）不适用
Efficacy and safety of fixed-dose combination Perindopril 5 mg/ Indapamide 1.25 mg / Amlodipine 5 mg versus Perindopril5 mg / Indapamide 1.25 mg single pill in patients withuncontrolled essential hypertension after 1 month of treatmentby Perindopril 5 mg / Indapamide 1.25 mg single pill withconditional titration based on blood pressure control up toPerindopril 10 mg/ Indapamide 2.5 mg / Amlodipine 10 mg.An international, multicentre, randomised, double blind,4-month superiority study.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men or women of any ethnic origin,
- •- Age = 18 years old or legal national majority,
- •- Confirmed essential uncontrolled hypertension,
- •- Normal or without any clinically significant anomaly 12-lead ECG (left ventricular hypertrophy is authorized at selection and during the study).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 314
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 134
排除标准
- •- Creatinine clearance value classifying them as moderate or severe renal failure
- •- History of hypertension known to be resistant to the free or fixed three-therapy combination with ACE-inhibitors, diuretics and calcium channel inhibitors,
- •- Treatment with more than 2 antihypertensive drugs at the selection visit,
- •- Allergy, hypersensitivity, history of intolerance to indapamide or to any other sulphonamides, to perindopril or any other ACE inhibitor, to amlodipine or any other dihydropyridine, or to any of the excipients,
- •- Congenital galactose intolerance, glucose and galactose malabsorption syndrome, deficit on lactase.
研究者
相似试验
进行中（未招募）
不适用
Efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine versus Perindopril / Indapamide single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril / Indapamidencontrolled essential hypertensionMedDRA version: 17.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2012-001658-24-HUInstitut de Recherches Internationales Servier448
进行中（未招募）
不适用
Efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine versus Perindopril / Indapamide single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril / Indapamidencontrolled essential hypertensionMedDRA version: 15.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2012-001658-24-SKInstitut de Recherches Internationales Servier448
进行中（未招募）
不适用
Efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine versus Perindopril / Indapamide single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril / Indapamidencontrolled essential hypertensionMedDRA version: 17.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2012-001658-24-PLInstitut de Recherches Internationales Servier448
进行中（未招募）
1 期
Efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine versus Perindopril / Indapamide single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril / IndapamideEUCTR2012-001658-24-CZInstitut de Recherches Internationales Servier448
进行中（未招募）
1 期
Efficacy and Safety of Fixed-Dose Combination atorvastatin/amlodipine/perindopril versus Fixed-Dose Combination of atorvastatin/ amlodipine in Patients with Hypertension and Dyslipidemia.hypertension and dyslipidemiaMedDRA version: 19.0Level: HLTClassification code 10020774Term: Vascular hypertensive disorders NECSystem Organ Class: 100000004866MedDRA version: 19.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861EUCTR2014-005378-12-BGInstitut de Recherche Internationales Servier830