Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared
 with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.
Inclusion Criteria:

 -  Age ≥ 65 years

 -  Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure
 (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff
 sphygmomanometer at the end of the wash-out period

 -  Written informed consent

 Exclusion Criteria:

 -  Secondary hypertension

 -  Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)

 -  Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L,
 clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L,
 clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L

 -  Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which
 could interfere with the cardiac rhythm

 -  Heart rate < 50 bpm

 -  Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF
 III-IV)

 -  Angina pectoris or myocardial infarction

 -  Cardiac surgery within the past 3 months prior to start the wash-out period

 -  Stroke within the past 6 months prior to start the wash-out period

 -  Renal insufficiency defined as creatininaemia > 2mg/dl

 -  Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post
 renal transplant

 -  Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate
 aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range

 -  Clinically significant metabolic and endocrine disease

 -  Autoimmune disease

 -  Previous history of angioedema

 -  Body mass index > 30kg/m2

 -  Arm circumference > 32 cm

 -  Any condition that may be likely to compromise the trial (alcohol or drug abuse,
 disability illness, etc.)

 -  Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present
 use of tricyclic antidepressant, corticosteroids or drugs known to affect blood
 pressure

 -  Investigational drug treatment within the past 30 days before the enrolment or
 concurrent participation to any other trial

 -  Sensitivity, significant adverse reaction or contraindications to the study drugs
 (telmisartan, enalapril, clonidine TTS)

 -  Predictable lack of patient co-operation