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

Phase 4CompletedNCT01997112

University of Edinburgh100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

100

Conditions

Blood Pressure

Interventions

ParacetamolDRUG

Placebo oral capsuleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Research Centre, Western General Hospital

Edinburgh, City Of Edinburgh, United Kingdom

Outcomes

Primary Outcomes

Systolic ambulatory blood pressure

Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.

Time frame: 14 days

Secondary Outcomes

Systolic clinic blood pressure

Difference in systolic clinic BP between the paracetamol and placebo treated groups.

Time frame: 14 days

Diastolic ambulatory blood pressure

Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.

Time frame: 14 days

Data from ClinicalTrials.gov

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