Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-25 @ 1:53 AM
Study NCT ID:
NCT02215733
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Angiotensin Receptor Blockers and the Risk of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1165781}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs', 'timeFrame': '16 years'}, {'measure': 'Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}], 'secondaryOutcomes': [{'measure': 'Number of patients with occurrences of lung cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of colorectal cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of breast cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of prostate cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of lung cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of breast cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}]}, 'conditionsModule': {'conditions': ['Neoplasm']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to assess whether angiotensin blockers (ARBs) and telmisartan in particular, are associated with an increased overall risk of the four most common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective was to explore these effects separately for each of the four cancers and in combination with angiotensin-converting-enzyme-inhibitors (ACEIs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients prescribed an antihypertensive agent between January 1, 1995 and December 31, 2008, with follow-up until December 31, 2010 Information extracted from United Kingdom General Practice Research Database (GPRD)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients prescribed an antihypertensive agent between 01-JAN-1995 and 31-DEC-2008 with at least two years of up-to-standard medical history in United Kingdom's General Practice Research Database (GPRD)\n\nExclusion Criteria:\n\n* History of cancer at any time prior to cohort entry"}, 'identificationModule': {'nctId': 'NCT02215733', 'briefTitle': 'The Use of Angiotensin Receptor Blockers and the Risk of Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'The Use of Angiotensin Receptor Blockers and the Risk of Cancer', 'orgStudyIdInfo': {'id': '502.599'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients prescribed antihypertensives', 'interventionNames': ['Drug: ARB', 'Drug: ACEI', 'Drug: Beta-blockers', 'Drug: Diuretics', 'Drug: Telmisartan']}], 'interventions': [{'name': 'ARB', 'type': 'DRUG', 'description': 'other than telmisartan', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'name': 'ACEI', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'name': 'Beta-blockers', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'name': 'Diuretics', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed antihypertensives']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}