EUCTR2017-001596-23-SI进行中（未招募）1 期
Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 461
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
- •Patients with essential arterial hypertension.*
- •Men and women aged = 18 years.
- •Written informed consent.
- •Ability to adhere to study protocol.
- •*Additional inclusion criteria for Amlessa®:
- •Patients with essential arterial hypertension:
- •o Naïve patients with systolic blood pressure (SBP) from 150 mmHg or higher AND/OR diastolic blood pressure (DBP) from 95 mmHg or higher (SBP = 150 AND/OR DBP = 90 mmHg for patients with type 2 diabetes mellitus)
- •o Uncontrolled patients on antihypertensive monotherapy with SBP from 140 mmHg or higher AND/OR DBP from 90 mmHg or higher (SBP = 140 AND/OR DBP = 85 mmHg for patients with type 2 diabetes mellitus).
- •o Uncontrolled patients on dual antihypertensive therapy (either in monoforms or FDC) with SBP from 140 mmHg or higher AND/OR DBP from 90 mmHg or higher (SBP = 140 AND/OR DBP = 85 mmHg for patients with type 2 diabetes mellitus).
- •*Additional inclusion criteria for Co-Amlessa®:
- •Patients with essential arterial hypertension (AH):
- •o Uncontrolled patients on dual antihypertensive therapy (either in monoforms or FDC, including perindopril+amlodipine combination) with SBP from 140 mmHg or higher AND/OR DBP from 90 mmHg or higher (SBP = 140 AND/OR DBP = 85 mmHg for patients with type 2 diabetes mellitus).
- •o Uncontrolled patients on triple antihypertensive therapy (either in monoforms or FDC) with SBP from 140 mmHg or higher AND/OR DBP from 90 mmHg or higher (SBP = 140 AND/OR DBP = 85 mmHg for patients with type 2 diabetes mellitus).
- •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 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 285
排除标准
- •History of adverse reactions or hypersensitivity associated with the use of the active substances, or any other components of the Investigational medicinal products (IMPs) used in the trial.
- •Hereditary/idiopathic angioedema.
- •Known secondary AH (e.g. pheochromocytoma, primary aldosteronism, renal artery stenosis)
- •Office measured Systolic blood pressure =200 mmHg
- •Unstable angina pectoris.
- •Acute heart failure and heart failure NYHA IV.
- •Antihypertensive drugs used for other indication than AH (e.g. tachyarrhythmia, glaucoma) less than 3 months before the study or in changed dosages less than 3 months before the study
- •Severe liver impairment OR biliary cirrhosis OR cholestasis OR hepatic encephalopathy
- •Renal dysfunction - GFR <60 ml/min (bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients with only 1 kidney, or post-renal transplant patients, dialysis patients
- •Any of the following clinically relevant laboratory or ECG findings
- •- significant anaemia with haemoglobin less than 100 g/l,
- •- serum AST and/or ALT and/or ALP and/or GammaGT of more than 3 x ULN (upper limit of normal)
- •- hyperkalaemia (serum potassium of more than 5 mmol/l)
- •- A-V block grade 2 or 3
- •- ECG signs of acute ischemia
- •Concurrent therapy with:
- •o aliskiren-containing products (in patients with diabetes mellitus or renal impairment)
- •o Estramustine
- •o Any not allowed” medication(s) listed in Study protocol section 6.2
- •Bradycardia with heart rate less than 50/min.
- •Female patients who are pregnant, planning to become pregnant.
- •Breastfeeding female patients.
- •Any significant acute condition (severe infection, exacerbation or uncontrolled phase of a chronic disease, major trauma, major surgery) within 30 days prior to screening visit.
- •Pathological clinical states (e.g. malignant diseases, excessive alcohol consumption, drug abuse or drug addiction, psychiatric conditions) or any life-threatening illness.
- •Patients currently participating in another clinical trial.
- •Patient’s refusal to participate with the investigator.
- •Normal average 24-hour SBP and DBP obtained by ABPM (<130/80 mmHg at baseline).
- •Severe orthostatic hypotension.
- •Patients to whom ß-blocker therapy cannot be discountinued in one day.
- •Previous or current therapy with perindopril and amlodipine and indapamide taken concomitantly all together as 3 separate tablets or as a fixed-dose combination.
- •In Amlessa® arm patients on previous or current therapy with perindopril and amlodipine taken concomitantly all together as 2 separate tablets or as a fixed-dose combination. (this exclusion criterion does not apply to Co-Amlessa® arm).
研究者
相似试验
进行中（未招募）
1 期
Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)ewly diagnosed and uncontrolled patients with essential arterial hypertension.MedDRA version: 20.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2017-001596-23-HRKrka, d.d., Novo mesto471
进行中（未招募）
1 期
Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)ewly diagnosed and uncontrolled patients with essential arterial hypertension.MedDRA version: 20.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2017-001596-23-PLKrka, d.d., Novo mesto471
已完成
4 期
Management of Newly Diagnosed and Uncontrolled Hypertension With Fixed-Dose Combination of Perindopril/Amlodipine and Perindopril/Indapamide/AmlodipineHypertensionNCT03738761KRKA471
已完成
3 期
Perindopril Amlodipine for the Treatment of HypertensionEssential HypertensionNCT01556997Symplmed Pharmaceuticals LLC837
尚未招募
1 期
A study combining blood pressure medication with standard treatment in advanced melanoma. ACE-IT-001Melanoma - UnresectableMelanoma - MetastaticCancer - Malignant melanomaACTRN12621000156886Calvary Mater Newcastle30