Hypertension MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: COVERSYL®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PERINDOPRIL ARGININE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name:
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range 152
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: - Demonstrate the superiority of 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. - 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. - Assess the efficacy of the S05179 SPC versus the tritherapy on the lowering of 24h-ABPM parameters after 8 weeks of treatment. - Assess the efficacy of the S05179 SPC versus the tritherapy on the lowering of home blood pressure monitoring parameters 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean ambulatory SBP over the 24h-period - Diastolic Blood Pressure (DBP), Mean Arterial Pressure and Pulse Pressure (PP). - Blood pressure control, blood pressure target, Response to the antihypertensive therapy - Ambulatory SBP and DBP measurements, Mean HR, Mean PP, Normalisation - 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 - Change from W000 to W008 - Proportion of patients at W008 - Description at W000 and W008 - Description at W000 and W008 | — |
Countries
Argentina, Armenia, Belarus, Brazil, Bulgaria, Croatia, Czechia, Czech Republic, Hungary, Italy, Kazakhstan, Latvia, Lithuania, Poland, Portugal, Romania, Russian Federation, Slovakia, Ukraine
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed