Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
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ClinicalTrials.gov Identifier: NCT02177461 |
Recruitment Status :
Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Telmisartan Drug: Enalapril Drug: Clonidine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 374 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | April 2000 |
Actual Primary Completion Date : | August 2002 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Hypertension
Arm | Intervention/treatment |
---|---|
Experimental: Telmisartan |
Drug: Telmisartan |
Active Comparator: Enalapril |
Drug: Enalapril |
Experimental: Telmisartan + clonidine TTS1 |
Drug: Telmisartan Drug: Clonidine |
Active Comparator: Enalapril + clonidine TTS1 |
Drug: Enalapril Drug: Clonidine |
Primary Outcome Measures :
- 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) [ Time Frame: Baseline and week 8 ]
Secondary Outcome Measures :
- Comparison of SBP ABPM tracing profile [ Time Frame: Week 8 and 24 ]
- Changes from baseline in trough cuff (sphygmomanometer) SBP [ Time Frame: Baseline, week 8 and 24 ]
- Smoothness index in comparison with baseline [ Time Frame: Baseline, week 8 and 24 ]
- Number of responders [ Time Frame: Week 8 and 24 ]
- Number of controlled responders [ Time Frame: Week 8 and 24 ]
- Incidence of adverse events [ Time Frame: 24 weeks ]
- Number of patients who withdraw due to adverse events [ Time Frame: 24 weeks ]
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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Additional Information:
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT02177461 |
Other Study ID Numbers: |
502.317 |
First Posted: | June 27, 2014 Key Record Dates |
Last Update Posted: | July 8, 2014 |
Last Verified: | July 2014 |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Telmisartan Clonidine Enalapril Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |