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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997112

Acronym

PATH-BP

Enrollment

100

Registered

2013-11-27

Start date

2014-01-31

Completion date

2019-10-31

Last updated

2019-10-02

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

Conditions

Blood Pressure

Keywords

Blood pressure, Hypertension, Paracetamol, Acetaminophen

Brief summary

The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

Detailed description

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.

Interventions

DRUGParacetamol

DRUGPlacebo oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Systolic ambulatory blood pressure	14 days	Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.

Secondary

Measure	Time frame	Description
Systolic clinic blood pressure	14 days	Difference in systolic clinic BP between the paracetamol and placebo treated groups.
Diastolic ambulatory blood pressure	14 days	Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026