Clinical trial NCT02177461: Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 374
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Comparison of SBP ABPM tracing profile
timeFrame: Week 8 and 24
measure: Changes from baseline in trough cuff (sphygmomanometer) SBP
timeFrame: Baseline, week 8 and 24
measure: Smoothness index in comparison with baseline
timeFrame: Baseline, week 8 and 24
measure: Number of responders
timeFrame: Week 8 and 24
measure: Number of controlled responders
timeFrame: Week 8 and 24
measure: Incidence of adverse events
timeFrame: 24 weeks
measure: Number of patients who withdraw due to adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References: