Cardiovascular area-Hypertension Circulatory System
Conditions
Interventions
CONTROL study is a multicenter, prospective, Non-Interventional, study among hypertensive patients with
3 months follow up. The study will be approved by local institutional review boa
Sponsors
Servier Egypt Scientific Office (Egypt)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for enrollment into the study: 1. Men or women with age between 30 and 75. 2. Patients with proved hypertension, a baseline mean BP > 140/90 mm Hg with or without Diabetes Mellitus type II. 3. Patients should be taking Coveram prior to enrollment in the study. 4. All patients will be treated for their hypertension with COVERAM as per the decision of the treating physician and according to the Product information leaflet ?PIL?. The decision for treatment with COVERAM will be made by the treating physician, based on medical judgment, prior to assessment of eligibility for the study. The management of the patient by the treating physician including the initiation of treatment with COVERAM will be independent and not affected by participation in the study. 5. Medical history of the patients should include switching of uncontrolled hypertensive patients on at least two medications to Coveram prior to the enrollment of the patients in the study. 6. Medical history of the patients should include switching to COVERAM from previous antihypertensive medication including at least 2 medications amongst ACEIs, ARBs, Diuretics & CCBs. 7. The patient must read, sign and receive a copy of the informed consent prior to study enrollment. 8. Patients registered to this study must be treated and followed up at the participating center according to the normal clinical practice.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following criteria will not be included in the study: 1. Newly diagnosed hypertensive patients not receiving any treatment at baseline or uncontrolled hypertensive patients receiving only one medication. 2. Hypertensive patients already treated with beta blockers at baseline or those with medical conditions that require to be treated with BB according to guidelines. 3. Patients with secondary hypertension. 4. Patients with stable coronary artery disease including those with MI history or stable angina pectoris. 5. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina pectoris within the past 6 months. 6. Hypertensive encephalopathy, stroke, or transient ischemic attack within the past 12 months. 7. New York Heart Association functional class I-IV congestive heart failure. 8. Hemodynamically significant cardiac valvular disease, Cardiac arrhythmias, sinus tachycardia. 9. Significant chronic renal impairment defined by estimated Glomerular Filtration Rate as those having eGFR = 60 ml/min/1.73 m2. 10. Significant liver disease as shown by SGPT/SGOT ? 2.5 times the upper limit of the normal range. 11. Gastrointestinal disease or surgery that might interfere with drug absorption. 12. Malignancy during the past 5 years. 13. Currently pregnant or lactating females. 14. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. 15. Known hypersensitivity to Perindopril, other ACEIs, Amlodipine, other CCB, Indapamide, other thiazide diuretic or other antihypertensive treatment use during the follow-up. 16. Simultaneous or previous participation ?in the 90 days prior to study entry? in a clinical trial using an experimental drug or device. 17. Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent. 18. Any medical condition that in judgment of the investigator would jeopardize the patient?s safety or the study drug?s evaluation for efficacy and safety. 19. Any of the contraindications linked to Perindopril, Amlodipine or COVERAM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| According to the guidelines and the normal clinical practice: at the doctor?s office after 5 min of rest, sitting position. Three BP measurements have to be taken and the mean of the last two will be used for the calculation of mean. Assessment of Study Medicines: Efficacy: Reduction in blood pressure to target values (140/90 mmHg or 130/80 mmHg, in patients with diabetes mellitus). Safety: Occurrence of any side effect leading to treatment discontinuation. All side effects will be monitored at each visit following the baseline visit during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving blood pressure control according to their background therapy, co-morbidity & number of cardiovascular risk factors. 2. Percentage of patients achieving blood pressure control with the different doses of Perindopril/Amlodipine combination or after adding Indapamide 1.5 mg SR or other treatment modification. 3. Effect of perindopril/Amlodipine combination with or without Indapamide SR or other treatment modification on short-term intravisit BPV and long-term visit-to-visit variability in SBP & DBP, its relationship with patient risk factors & comorbidities 4. Occurrence of any side effects leading to treatment discontinuation. | — |
Countries
Egypt
Outcome results
None listed