Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Enalapril; Drug: Clonidine

• Registration Number: NCT02177461
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2002-08
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan + clonidine TTS1	Clonidine	-
Telmisartan + clonidine TTS1	Telmisartan	-
Telmisartan	Telmisartan	-
Enalapril	Enalapril	-
Enalapril + clonidine TTS1	Clonidine	-
Enalapril + clonidine TTS1	Enalapril	-

Primary Outcome Measures

Name	Time	Method
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

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