PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
PATH-BP
2 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 2, 2019
October 1, 2019
5.4 years
November 21, 2013
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic ambulatory blood pressure
Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.
14 days
Secondary Outcomes (2)
Systolic clinic blood pressure
14 days
Diastolic ambulatory blood pressure
14 days
Study Arms (2)
Paracetamol
ACTIVE COMPARATORparacetamol 1g (500mg x2) four times daily for 14 day period
Placebo
PLACEBO COMPARATORMatched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- ≥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)
- 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.
You may not qualify if:
- History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST\>50IU/L) or stage 3-5 chronic kidney disease.
- History of overdose or suicidal ideation
- Patients weighing \<55kgs.
- Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- British Heart Foundationcollaborator
- National Health Service, United Kingdomcollaborator
Study Sites (1)
Clinical Research Centre, Western General Hospital
Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom
Related Publications (1)
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.
PMID: 35130054DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 27, 2013
Study Start
January 1, 2014
Primary Completion
June 4, 2019
Study Completion
October 1, 2019
Last Updated
October 2, 2019
Record last verified: 2019-10