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

University of Edinburgh

Status and phase

Completed

Phase 4

Conditions

Blood Pressure

Treatments

Drug: Paracetamol

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT01997112

PG/13/26/3012 8 (Other Grant/Funding Number)

PATHBP_2013

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.