Evaluation of the Clinical Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Single-pill After 2 Months of Treatment Versus Free Combination, Perindopril 4 mg / Indapamide 1.25 mg + Amlodipine 5 mg Given Separately at the Same Time, With Conditional Titration Based on Blood Pressure Control in Patients With Essential Hypertension Uncontrolled After 1 Month With Perindopril 4 mg / Indapamide 1.25 mg Bi-therapy.
Overview
- Phase
- Phase 3
- Intervention
- Fixed [Per/Ind/Aml]
- Conditions
- Hypertension
- Sponsor
- Institut de Recherches Internationales Servier
- Enrollment
- 532
- Locations
- 42
- Primary Endpoint
- Sitting SBP change after two months of treatment
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women of Asian origin
- •≥18 years old
- •Treated for essential hypertension
- •Having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit
- •Having at the selection visit a sitting SBP≥140 and \<180 mmHg and DBP≥90 and \<110 mmHg
Exclusion Criteria
- •Known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit
- •Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit
Arms & Interventions
Fixed [Per/Ind/Aml]
From inclusion to Month 2, patients receive the fixed combination of perindopril 5 mg / indapamide 1.25 mg / amlodipine 5 mg (S06593). From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg). From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, for patients who were up-titrated at Month 2 visit: perindopril 10 mg / indapamide 2.5 mg / amlodipine 10 mg or for patients who were not yet up-titrated: perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg.
Intervention: Fixed [Per/Ind/Aml]
Free [Per/Ind + Aml]
From inclusion to Month 2, patients receive the free combination of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg. From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg for patients). From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie for patients who were up-titrated at Month 2 visit: double dose of perindopril 4 mg / indapamide 1.25 mg plus double dose of amlodipine 5 mg or for patients who were not yet up-titrated:double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg.
Intervention: Free [Per/Ind + Aml]
Outcomes
Primary Outcomes
Sitting SBP change after two months of treatment
Time Frame: Baseline safety visit, Month 2 follow-up visit
Office sitting Systolic Blood Pressure (SBP) change from baseline to last post-baseline value over the period from Month 0 to month 2
Secondary Outcomes
- Sitting DBP change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting DBP change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Sitting SBP change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Sitting DBP change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Sitting Pulse Pressure change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting SBP change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Sitting Mean Arterial Pressure change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Adverse events between Month 0 and Month 2(Up to the 2 month follow-up visit)
- Adverse events between Month 0 and Month 6(Up to the 6 month final visit)
- Sitting Mean Arterial Pressure change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting Mean Arterial Pressure change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Response to the treatment at two months(Month 2 follow-up visit)
- Control of Blood Pressure at two months(Month 2 follow-up visit)