Evaluation of controlling high blood pressure using a combined amlodipine and perindopril arginine approach in Morocco
| ISRCTN | ISRCTN18135766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18135766 |
| Secondary identifying numbers | IC4-05985-014-MAR |
- Submission date
- 26/03/2024
- Registration date
- 05/04/2024
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
The SYNERGIA study was conducted in private healthcare facilities in Morocco to assess how effective a combination of two medications, amlodipine and perindopril arginine, is in managing high blood pressure (hypertension).
Who can participate?
Patients aged 18 years or older who are hypertensive and previously treated with amlodipine monotherapy, uncontrolled and for whom the treating physician decides to add perindopril arginine.
What does the study involve?
The research focused on adults who were already taking amlodipine for their high blood pressure but were still not seeing improvement. In response, their doctors decided to add perindopril arginine to their treatment plan. The main goal of the study is to see how effective this combination of medications (amlodipine and perindopril arginine) is for patients who are still struggling with high blood pressure despite taking amlodipine alone. The study lasted for 90 days.
This study, which involved 1600 patients from different medical centers across Morocco, looked at vital signs like blood pressure (both systolic and diastolic) and heart rate at three points: 30, 60, and 90 days into the study.
What are the possible benefits and risks of participating?
The combination of amlodipine and perindopril arginine have been proven in studies conducted in several countries showing the benefits of a fixed combination amlodipine-perindopril in lowering blood pressure, heart rate, improving medication adherence and safety, and reducing adverse events.
Where is the study run from?
SERVIER (Morocco)
When is the study starting and how long is it expected to run for?
March 2023 to March 2024
Who is funding the study?
SERVIER (Morocco)
Who is the main contact?
dansong@gaya-holding.com
Abouloula.sara@gmail.com
Contact information
Public, Scientific
23, rue banimalik, RDC, aviation
Rabat
10180
Morocco
 ORCID ID |
0009-0002-5704-2861 |
|---|---|
| Phone | +212 703112122 |
| dansong@gaya-holding.com |
Principal Investigator
4, rue Abdelhak el Kadmiri, Chantimar, maarif
Casablanca
20000
Morocco
| Phone | +212 6 61328545 |
|---|---|
| Abouloula.sara@gmail.com |
Study information
| Study design | Prospective multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of hypertension management with an amlodipine and perindopril arginine-based strategy in Morocco |
| Study acronym | SYNERGIA-MOROCCO |
| Study hypothesis | Hypertensive patients, initially uncontrolled on amlodipine monotherapy, whose treating physician adds perindopril arginine as adjunctive therapy to achieve hypertension control, and then switches to a fixed-dose combination of amlodipine-perindopril arginine, exhibit effective hypertension management. |
| Ethics approval(s) |
Approved 23/10/2023, Committee for Biomedical Research (CERB) of The Faculty of Medicine and Pharmacy- Rabat (Faculty of Medicine and Pharmacy- Rabat, Rabat, 10000, Morocco; +212 537 77 35 60; guedirak@yahoo.fr), ref: 48/23 |
| Condition | Hypertension |
| Intervention | This is an observational study that involves the observation of 1600 hypertensive patients in Morocco over a span of 90 days. Physicians will adapt medication (amlodipine-perindopril arginine fixed combination) dosages as required to regulate blood pressure levels, while monitoring vital signs such as blood pressure and heart rate at 30, 60 and 90 days. Additionally, other factors such as medical history will be taken into consideration during the evaluation process. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | amlodipine-perindopril arginine fixed combination |
| Primary outcome measure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) in the supine position at baseline, 30, 60 and 90 days |
| Secondary outcome measures | 1. Supine SBP and DBP between the start of the study and the start of fixed therapy measured using a sphygmomanometer 2. Reported side effects between the start of the amlodipine-perindopril arginine fixed combination and the end of the study measured using patient records |
| Overall study start date | 01/03/2023 |
| Overall study end date | 15/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1600 |
| Total final enrolment | 1614 |
| Participant inclusion criteria | 1. Men or women aged ≥18 years who document informed consent. 2. Hypertensive patients previously treated with amlodipine monotherapy, uncontrolled and for whom the treating physician decides to add perindopril arginine. |
| Participant exclusion criteria | 1. Age < 18 years 2. Pregnancy, breastfeeding or possibility of becoming pregnant during the study 3. Current participation in another randomized study or within the previous 3 months 4. Known symptomatic orthostatic hypotension 5. Known hyperkalemia or hypokalemia 6. History of arterial hypertension known to be resistant to the free combination or in a single tablet with perindopril and calcium channel blockers or contraindications to treatment with perindopril or amlodipine 7. Known secondary hypertension or complicated hypertension 8. Known renal insufficiency: patients with a creatinine clearance value classifying them as moderate or severe renal insufficiency according to the national or international classification of chronic renal insufficiency or bilateral stenosis of the renal artery or stenosis at solitary kidney or history of gout 9. Known complicated liver disease 10. Chronic pancreatitis 11. History of heart disease: cardiogenic shock, myocardial infarction within 6 months prior to selection, hemodynamically unstable heart failure after acute myocardial infarction, coronary revascularization within 6 months previous congestive heart failure within 6 months prior to selection or history of congestive heart failure with NYHA grade III or IV, severe aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy 12. Recent ventricular rhythm disorders 13. History of cerebrovascular disease 14. Hypersensitivity to active substances, other sulfonamides, dihydropyridine derivatives and any ACE inhibitors 15. History of angioedema (angioedema) associated with previous treatment with an ACE inhibitor 16. Hereditary/idiopathic angioedema 17. Hepatic encephalopathy 18. Concomitant use of the fixed combination of perindopril and amlodipine with products containing aliskiren in patients with diabetes mellitus or renal insufficiency (GFR < 60 ml/min/1.73 m²) 19. Any other contraindication according to the SPC (Summary of Product Characteristics) of the medicinal product. |
| Recruitment start date | 30/10/2023 |
| Recruitment end date | 13/12/2023 |
Locations
Countries of recruitment
- Morocco
Study participating centre
10000
Morocco
Sponsor information
Industry
Immeuble ZEVACO. Lotissement Fath 4
Bd Abdelhadi Boutaleb
Casablanca
20180
Morocco
| Phone | +212 6 65 15 60 04 |
|---|---|
| Sara.ABOULOULA@servier.com | |
| Website | https://servier.ma/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed in the current study are not expected to be made available due to the data privacy of Morocco. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 03/06/2023 | 28/03/2024 | No | No |
Additional files
Editorial Notes
28/03/2024: Trial's existence confirmed by Committee for Biomedical Research (CERB) of The Faculty of Medicine and Pharmacy- Rabat.
