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Completed

NCT Number: NCT01997112

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

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

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Research Centre, Western General Hospital

Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol

Drug

Other names: Acetaminophen

Placebo oral capsule

Drug

Primary outcomes

  1. Systolic ambulatory blood pressure

    Time frame: 14 days

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

Secondary outcomes

  1. Systolic clinic blood pressure

    Time frame: 14 days

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

  2. Diastolic ambulatory blood pressure

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • National Health Service, United Kingdom

Registry information

Acronym: PATH-BP

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2013
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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