A comparison of a single-pill combination of perindopril/indapamide/amlodipine/bisoprolol with perindopril, indapamide and amlodipine in patients with essential hypertension whoseblood pressure remains high on perindopril, indapamide and amlodipine treatment.

Phase 1

Conditions: Hypertension
MedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2020-004891-16-IT

Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 968

Inclusion Criteria

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. 12-lead electrocardiogram (ECG) without any recent clinically significant abnormality.
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

Exclusion Criteria

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
Main Objective: Demonstration of the superiority of the S05179 Single-Pill Combination (SPC) over the tritherapy on the lowering of office sitting SBP after 8 weeks of treatment.;Primary end point(s): Office sitting SBP;Timepoint(s) of evaluation of this end point: Change from W000 to W008;Secondary Objective: - Demonstrate the superiority of the S05179 SPC over the tritherapy on the lowering of ambulatory systolic blood pressure (SBP) over the entire 24-hour period (from 24h-ABPM) after 8 weeks of treatment.<br>- Assess the efficacy of the S05179 SPC versus the tritherapy on the lowering of other sitting office blood pressure (BP) parameters after 8 weeks of treatment.<br>- Assess the efficacy of the S05179 SPC versus the tritherapy on the lowering of 24h-ABPM parameters after 8 weeks of treatment.<br>- Assess the efficacy of the S05179 SPC versus the tritherapy on the lowering of home blood pressure monitoring parameters after 8 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Mean ambulatory SBP over the 24h-period<br>- Diastolic Blood Pressure (DBP), Mean Arterial Pressure and Pulse Pressure (PP).<br>- Blood pressure control, blood pressure target, Response to the antihypertensive therapy<br>- Ambulatory SBP and DBP measurements, Mean HR, Mean PP, Normalisation<br>- Mean Home Diastolic Blood Pressure and Home Blood Pressure Monitoring, Mean home PP, Normalisation;Timepoint(s) of evaluation of this end point: - Change from W000 to W008<br>- Change from W000 to W008<br>- Proportion of patients at W008<br>- Description at W000 and W008<br>- Description at W000 and W008

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