Evaluation of controlling high blood pressure using a combined amlodipine and perindopril arginine approach in Morocco
- Conditions
- HypertensionCirculatory System
- Registration Number
- ISRCTN18135766
- Lead Sponsor
- SERVIER (Morocco)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1614
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Systolic blood pressure (SBP) and diastolic blood pressure (DBP) in the supine position at baseline, 30, 60 and 90 days
- Secondary Outcome Measures
Name Time Method 1. Supine SBP and DBP between the start of the study and the start of fixed therapy measured using a sphygmomanometer <br>2. Reported side effects between the start of the amlodipine-perindopril arginine fixed combination and the end of the study measured using patient records