Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT01274494
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-10', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance rate', 'timeFrame': '6 months', 'description': 'Identify the percentage of subjects compliant to their antihypertensive treatment.'}], 'secondaryOutcomes': [{'measure': 'Health Related Quality of Life (MINICHAL Score)', 'timeFrame': '6 months', 'description': 'To compare and identify changes in the quality of life before and after anti-hypertensive treatment.'}, {'measure': 'Type of pharmacological treatments', 'timeFrame': '6 months', 'description': 'To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.'}, {'measure': 'Factors affecting adherence to treatment', 'timeFrame': '6 months', 'description': 'To identify associated factors that may alter adherence to anti-hypertensive treatment.'}, {'measure': 'Compliance rate by antihypertensive regimen used', 'timeFrame': '6 months', 'description': 'To compare treatment rate for different antihypertensive regimen used'}, {'measure': 'Percentage of controlled patients', 'timeFrame': '6 months', 'description': 'To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['High Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'multi-centre survey of patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 21 years of age\n* Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)\n* Patients capable of providing an informed consent\n\nExclusion Criteria:\n\n* Patients with secondary hypertension\n* Pregnant women or nursing mothers\n* Patients with acute illnesses or psychiatric diagnosis'}, 'identificationModule': {'nctId': 'NCT01274494', 'briefTitle': 'COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication', 'orgStudyIdInfo': {'id': 'NIS-CME-ATA-2010/1'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}