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

October 1, 2019 updated by: University of Edinburgh
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • City Of Edinburgh
      • Edinburgh, City Of Edinburgh, United Kingdom, EH4 2XU
        • Clinical Research Centre, Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paracetamol
paracetamol 1g (500mg x2) four times daily for 14 day period
Drug: Paracetamol
Other Names:
  • Acetaminophen
Placebo Comparator: Placebo
Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days
Drug: Placebo oral capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation
National Health Service, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 4, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATHBP_2013
  • PG/13/26/3012 8 (Other Grant/Funding Number: British Heart Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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