Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Clonidine; Enalapril; Enalaprilat; Telmisartan

Criteria

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