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Evaluation of controlling high blood pressure using a combined amlodipine and perindopril arginine approach in Morocco

Effectiveness of hypertension management with an amlodipine and perindopril arginine-based strategy in Morocco

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18135766
Enrollment
1600
Registered
2024-04-05
Start date
2023-10-30
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Circulatory System

Interventions

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 c

Sponsors

SERVIER (Morocco)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) in the supine position at baseline, 30, 60 and 90 days

Secondary

MeasureTime frame
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

Countries

Morocco

Contacts

Public ContactDhaud Odei Ansong
dansong@gaya-holding.com+212 703112122

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026