PAracetamol Treatment in Hypertension: effect on Blood Pressure (PATH-BP) Study

Paracetamol treatment in hypertension: effect on blood pressure - The PATH-BP study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003204-40-GB

Enrollment

110

Registered

2013-12-04

Start date

2014-01-20

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension MedDRA version: 14.1 Level: PT Classification code 10005729 Term: Blood pressure ambulatory System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1

Interventions

Trade Name: Paracetamol capsules 500mg Product Name: Paracetamol capsules 500mg Product Code: Not applicable (Licensed product) Pharmaceutical Form: Cap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: =18 years old, men or post-menopausal women. Half of the patients recruited will be women (to allow PG measurement). Treated hypertensive patients with an average daytime ABPM =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria: History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease. Patients with a 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 NSAIDs, oral anticoagulants or corticosteroids.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of parcetamol on blood pressure in hypertensives adults taking or not taking antihypertensive medications.;Secondary Objective: Not applicable.;Primary end point(s): Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods. ;Timepoint(s) of evaluation of this end point: Daytime systolic ambulatory BP will be assessed at the start and end of each 14 day period of study drugs.	—

Measure

Time frame

Main Objective: To determine the effect of parcetamol on blood pressure in hypertensives adults taking or not taking antihypertensive medications.;Secondary Objective: Not applicable.;Primary end point(s): Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods. ;Timepoint(s) of evaluation of this end point: Daytime systolic ambulatory BP will be assessed at the start and end of each 14 day period of study drugs.

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Secondary

Measure	Time frame
Secondary end point(s): i)Difference in clinic systolic BP between paracetamol and placebo periods ii)Difference in daytime diastolic ambulatory BP between paracetamol and placebo periods iii)Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods in patients taking and not taking antihypertensive medications ;Timepoint(s) of evaluation of this end point: Clinic systolic BP will be assessed on day 0, day 4&7, and day 14 of study drugs. Ambulatory BP will be assessed on day 0 and day 14 (ie start and end of study drugs).	—

Measure

Time frame

Secondary end point(s): i)Difference in clinic systolic BP between paracetamol and placebo periods ii)Difference in daytime diastolic ambulatory BP between paracetamol and placebo periods iii)Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods in patients taking and not taking antihypertensive medications ;Timepoint(s) of evaluation of this end point: Clinic systolic BP will be assessed on day 0, day 4&7, and day 14 of study drugs. Ambulatory BP will be assessed on day 0 and day 14 (ie start and end of study drugs).

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Countries

United Kingdom

Contacts

Public ContactProfessor Davide Webb

Queen’s Medical Research Institute

d.j.webb@ed.ac.uk01312429216

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026