Male or female outpatients, aged 65-89 years, with mild to moderate essential hypertension (sDBP>=90mmHg and sSBP>=140mmHg)
Conditions
Interventions
Trade Name: Omesar 10mg
Product Name: OLMESARTAN MEDOXOMIL
Product Code: Cs-866
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLMESARTAN MEDOXOMIL
CAS Number: 144689-63-4
Current Sponso
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes responding to the following criteria will be enrolled: – age >65 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Grade 3 essential arterial hypertension (systolic arterial pressure when seated ³ 180 mmHg and/or diastolic arterial pressure when seated ³ 110 mmHg); – secondary or malign arterial hypertension; – unstable angina; – Atrial fibrillation; – Frequent ventricular ectopic beats or other arrhytmias which could interfere with blood pressure recording ; – cardiac arrhythmia requiring administration of anti-arrhythmic medicines; – heart failure requiring medical treatment; – myocardial infarction in the previous 6 months; – cerebrovascular events in the previous 6 months; – haemodynamically significant valvulopathy; – hereditary/idiopathic angioedema; – history of angioedema associated with previous ACE-inhibitor therapy; – bilateral renal arterial stenosis, or unilateral for patients with a single kidney; – severe concurrent pathology (tumour, AIDS, chronic hepatosis, etc.); – dementia, psychosis, alcoholism or chronic abuse of medicines, drugs or psychoactive substances; – chronic use of concomitant therapies among those not permitted (that might influence blood pressure values as mentioned in chapter 5.8) and which can not be suspended without harm to the patient; – hypersensitivity or contraindications to use of the product under study; – history of side effects with ACE-inhibitors or AT1-antagonists; – pregnancy or breast-feeding; – participation in other clinical trials in the previous 4 months; – conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons; – risk of low patient cooperation – hepatic pathology (transaminasaemia >3 times greater than normal upper limit); – renal insufficiency (creatininaemia >200 µmol/l or 2 mg/dl); – hypokalemia (5,0 mEq/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of olmesartan medoxomil in mild to moderate hypertension in elderly subjects (65-89 yrs) in relation to ramipril by comparing the proportion of patients achieving normalization of the seated Diastolic Blood Pressure at week 12;Secondary Objective: To evaluate the change from baseline (Visit V0) to week 12 (Visit V3) and to week 48 (Visit V8) in the 24- hour ambulatory monitoring of arterial blood pressure To evaluate the percentage of patients “normalised (seated BP <140/90 for Non diabetic patients; seated BP <130/80 mmHg for Diabetic patients) and responders (reduction of 20 mmHg in seated SBP and reduction of 10 mmHg in seated DBP in comparison with the baseline values) after 2, 6, 12 weeks of monotherapy with olmesartan medoxomil in comparison with ramipril in mild-moderate hypertension To determine the onset of the seated DBP/SBP lowering effect after treatment To evaluate the efficacy of olmesartan medoxomil in comparison with ramipril by reducing Pulse Pressure defined as the difference between seated systolic blood pressure and seated diastolic blood pressure at week 12ü To assess long term (42 weeks) safety and tolerability of olmesartan medoxomil 40mg ;Primary end point(s): To evaluate the efficacy of two treatment groups (Olmesartan medoxomil vs Ramipril) by comparing the proportion of patients achieving normalisation of the arterial diastolic blood pressure. | — |
Countries
Germany, Ireland, Spain
Outcome results
None listed