Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-11 @ 6:57 AM
Study NCT ID:
NCT02177461
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D004656', 'term': 'Enalapril'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* 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\n* Written informed consent\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)\n* 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\n* Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm\n* Heart rate \\< 50 bpm\n* Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)\n* Angina pectoris or myocardial infarction\n* Cardiac surgery within the past 3 months prior to start the wash-out period\n* Stroke within the past 6 months prior to start the wash-out period\n* Renal insufficiency defined as creatininaemia \\> 2mg/dl\n* Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant\n* Liver insufficiency, defined as bilirubinaemia \\> 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) \\> twice the upper normal range\n* Clinically significant metabolic and endocrine disease\n* Autoimmune disease\n* Previous history of angioedema\n* Body mass index \\> 30kg/m2\n* Arm circumference \\> 32 cm\n* Any condition that may be likely to compromise the trial (alcohol or drug abuse, disability illness, etc.)\n* Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure\n* Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial\n* Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, enalapril, clonidine TTS)\n* Predictable lack of patient co-operation'}, 'identificationModule': {'nctId': 'NCT02177461', 'briefTitle': 'Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '502.317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan', 'interventionNames': ['Drug: Telmisartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'interventionNames': ['Drug: Enalapril']}, {'type': 'EXPERIMENTAL', 'label': 'Telmisartan + clonidine TTS1', 'interventionNames': ['Drug: Telmisartan', 'Drug: Clonidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril + clonidine TTS1', 'interventionNames': ['Drug: Enalapril', 'Drug: Clonidine']}], 'interventions': [{'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan', 'Telmisartan + clonidine TTS1']}, {'name': 'Enalapril', 'type': 'DRUG', 'armGroupLabels': ['Enalapril', 'Enalapril + clonidine TTS1']}, {'name': 'Clonidine', 'type': 'DRUG', 'armGroupLabels': ['Enalapril + clonidine TTS1', 'Telmisartan + clonidine TTS1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}