Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT01997112
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2013-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
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': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic ambulatory blood pressure', 'timeFrame': '14 days', 'description': 'Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.'}], 'secondaryOutcomes': [{'measure': 'Systolic clinic blood pressure', 'timeFrame': '14 days', 'description': 'Difference in systolic clinic BP between the paracetamol and placebo treated groups.'}, {'measure': 'Diastolic ambulatory blood pressure', 'timeFrame': '14 days', 'description': 'Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood pressure', 'Hypertension', 'Paracetamol', 'Acetaminophen'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '35130054', 'type': 'DERIVED', 'citation': 'MacIntyre IM, Turtle EJ, Farrah TE, Graham C, Dear JW, Webb DJ; PATH-BP (Paracetamol in Hypertension-Blood Pressure) Investigators*. Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial. Circulation. 2022 Feb 8;145(6):416-423. doi: 10.1161/CIRCULATIONAHA.121.056015. Epub 2022 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.', 'detailedDescription': 'A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)\n* Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) \\<150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but \\<150/95.\n\nExclusion Criteria:\n\n* History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST\\>50IU/L) or stage 3-5 chronic kidney disease.\n* History of overdose or suicidal ideation\n* Patients weighing \\<55kgs.\n* Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.'}, 'identificationModule': {'nctId': 'NCT01997112', 'acronym': 'PATH-BP', 'briefTitle': 'PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study', 'orgStudyIdInfo': {'id': 'PATHBP_2013'}, 'secondaryIdInfos': [{'id': 'PG/13/26/3012 8', 'type': 'OTHER_GRANT', 'domain': 'British Heart Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': 'paracetamol 1g (500mg x2) four times daily for 14 day period', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'armGroupLabels': ['Paracetamol']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'City Of Edinburgh', 'country': 'United Kingdom', 'facility': 'Clinical Research Centre, Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}, {'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}