Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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A PROBE (Prospective, Randomised, Open-Label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Enalapril
* Drug: Clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan<br> | Drug: Telmisartan<br> <br> |
| Active Comparator: Enalapril<br> | Drug: Enalapril<br> <br> |
| Experimental: Telmisartan + clonidine TTS1<br> | Drug: Telmisartan<br> <br> Drug: Clonidine<br> <br> |
| Active Comparator: Enalapril + clonidine TTS1<br> | Drug: Enalapril<br> <br> Drug: Clonidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values) |  | Baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SBP ABPM tracing profile |  | Week 8 and 24 | 
| Changes from baseline in trough cuff (sphygmomanometer) SBP |  | Baseline, week 8 and 24 | 
| Smoothness index in comparison with baseline |  | Baseline, week 8 and 24 | 
| Number of responders |  | Week 8 and 24 | 
| Number of controlled responders |  | Week 8 and 24 | 
| Incidence of adverse events |  | 24 weeks | 
| Number of patients who withdraw due to adverse events |  | 24 weeks |