Hypertension
Conditions
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.
Interventions
DRUGFixed [Per/Ind/Aml]
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
DRUGFree [Per/Ind + Aml]
Free dose combination of Perindopril/Indapamide and Amlodipine
Sponsors
Institut de Recherches Internationales Servier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main 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 Main
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sitting SBP change after two months of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Sitting SBP change from month 2 to month 4 | Month 2 follow-up visit, Month 4 follow-up visit | Office sitting Systolic Blood Pressure (SBP) change from month 2 to month 4 |
| Sitting SBP change from month 4 to month 6 | Month 4 follow-up visit, Month 6 follow-up visit | Office sitting Systolic Blood Pressure (SBP) change from month 4 to month 6 |
| Sitting DBP change after two months of treatment | Baseline safety visit, Month 2 follow-up visit | Office sitting Diastolic Blood Pressure (DBP) change from baseline to last post-baseline value over the period from Month 0 to month 2 |
| Sitting DBP change from month 2 to month 4 | Month 2 follow-up visit, Month 4 follow-up visit | Office sitting Diastolic Blood Pressure (DBP) change from month 2 to month 4 |
| Sitting DBP change from month 4 to month 6 | Month 4 follow-up visit, Month 6 follow-up visit | Office sitting Diastolic Blood Pressure (DBP) change from month 4 to month 6 |
| Sitting Mean Arterial Pressure change after two months of treatment | Baseline safety visit, Month 2 follow-up visit | Sitting Mean Arterial Pressure (MAP) change from baseline to last post-baseline value over the period from Month 0 to month 2 with MAP=2/3 DBP+1/3 SBP |
| Sitting Mean Arterial Pressure change from month 2 to month 4 | Month 2 follow-up visit, Month 4 follow-up visit | Sitting Mean Arterial Pressure (MAP) change from from month 2 to month 4 , with MAP=2/3 DBP+1/3 SBP |
| Sitting Mean Arterial Pressure change from month 4 to month 6 | Month 4 follow-up visit, Month 6 follow-up visit | Sitting Mean Arterial Pressure (MAP) change from from month 4 to month 6, with MAP=2/3 DBP+1/3 SBP |
| Sitting Pulse Pressure change after two months of treatment | Baseline safety visit, Month 2 follow-up visit | Sitting Pulse Pressure change from baseline to last post-baseline value over the period from Month 0 to month 2, with Pulse Pressure=SBP-DBP |
| Response to the treatment at two months | Month 2 follow-up visit | Number of patients responders, ie: with control of Blood Pressure : sitting SBP \<140 mmHg and sitting DBP \<90 mmHg) and/or sitting SBP decrease from baseline ≥20 mmHg or sitting DBP decrease from baseline ≥10 mmHg. |
| Control of Blood Pressure at two months | Month 2 follow-up visit | Number of patients with Blood pressure controlled, ie : with sitting SBP \<140 mmHg and sitting DBP \< 90 mmHg |
| Adverse events between Month 0 and Month 2 | Up to the 2 month follow-up visit | Number experiencing treatment emergent adverse events between month 0 and month 2 |
| Adverse events between Month 0 and Month 6 | Up to the 6 month final visit | Number experiencing treatment emergent adverse events between month 0 and month 6 |
Countries
China
Outcome results
None listed