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)
- Conditions
- ewly diagnosed and uncontrolled patients with essential arterial hypertension.MedDRA version: 20.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001596-23-SI
- Lead Sponsor
- Krka, d.d., Novo mesto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 461
• 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
• 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 Lithium
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to establish the efficacy and safety of fixed-dose combination (FDC) of perindopril/amlodipine (Amlessa®) and fixed-dose combination of perindopril/indapamide/amlodipine (Co-Amlessa®) in wide populations of uncontrolled patients with arterial hypertension (AH) with special focus on effective continuous 24-hour blood pressure (BP) control. The purpose is also to establish the correlation between 24-hour central and peripheral BP.;Secondary Objective: Not applicable;Primary end point(s): Responder rate after 16 weeks (visit 5): proportion of patients reaching normal office blood pressure (NBP)*. <br>* Normal (office) blood pressure (NBP): SBP < 140 mmHg and DBP < 90 mmHg; patients with type 2 diabetes mellitus: SBP < 140 mmHg and DBP < 85 mmHg);Timepoint(s) of evaluation of this end point: After 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method