Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT02177461
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02177461
Study Brief:
Protocol Section:
NCT02177461