Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Clonidine; Drug: Enalapril; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177461

502.317

Details and patient eligibility

About

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.

Enrollment: 374 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 4 patient groups

Telmisartan

Experimental group

Treatment:

Drug: Telmisartan

Enalapril

Active Comparator group

Treatment:

Drug: Enalapril

Telmisartan + clonidine TTS1

Experimental group

Treatment:

Drug: Telmisartan

Drug: Clonidine

Enalapril + clonidine TTS1

Active Comparator group

Treatment:

Drug: Enalapril

Drug: Clonidine