Hypertension
Conditions
Brief 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.
Interventions
DRUGTelmisartan
DRUGEnalapril
DRUGClonidine
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Comparison of SBP ABPM tracing profile | Week 8 and 24 |
| Incidence of adverse events | 24 weeks |
| Number of patients who withdraw due to adverse events | 24 weeks |
| Number of controlled responders | Week 8 and 24 |
Outcome results
None listed