A comparison of a single-pill combination of perindopril/indapamide/amlodipine/bisoprolol with perindopril,indapamide and amlodipine in patients with essential hypertension whose blood pressure remains high on perindopril, indapamide and amlodipine treatment.
- Conditions
- HypertensionMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-004891-16-LT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 968
1. Essential hypertension in moderate to high cardiovascular risk patients treated with 3 antihypertensive drugs, including a diuretic, at the optimal tolerated doses for at least 1 month prior to the visit.
2. Without change in antihypertensive therapy within the month prior to the visit.
3. Office sitting SBP = 140 mmHg at selection visits.
4. Patients for whom the addition of a beta-blocker is considered as the best therapeutic alternative according to the investigator.
5. A recent (< 6 months) renal echography or Computerised Tomography scan (CT scan) or angiography without findings for secondary hypertension.
6. Office sitting SBP = 140 mmHg at ASS2 and W000 visits.
7. Mean ambulatory SBP = 130 mmHg at W000 visit over the 24h-period.
8. W000 12-lead electrocardiogram (ECG) without clinically significant abnormality that in the opinion of the investigator should prevent the participation of the patient in 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 816
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 152
1. Pregnant and lactating women
2. No willing to refrain from consuming grapefruit and all beverages containing grapefruit during the study
3. Contra-indications to treatment with perindopril, indapamide, amlodipine or bisoprolol including known hypersensitivity / history of intolerance to perindopril, indapamide, amlodipine, bisoprolol or any excipient
4. Apparent or suspected secondary hypertension
5. Any history or known severe disease likely to interfere with the conduct of the study or history of mental or psychiatric disorder
6. Non-recovered pancreatic diseases
7. Current treatment with beta-blockers. Past history of beta-blocker treatment is authorised assuming that beta-blockers have been stopped, according to each beta-blocker wash-out period, to avoid any rebound effect at the time of selection
8. Current potassium supplementation
9. Requirement for any treatment that may affect hypertension for reason other than to treat hypertension and which cannot be discontinued at selection
10. Laboratory clinically significant abnormal values at ASS2 or W000 visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method