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

Phase 4

Completed

• Conditions: Blood Pressure
• Interventions: Drug: Placebo oral capsule; Drug: Paracetamol

• Registration Number: NCT01997112
• Lead Sponsor: University of Edinburgh

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.

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Study Start: 2014-01
• Primary Completion: 2019-06-04
• Status Verified: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days
Paracetamol	Paracetamol	paracetamol 1g (500mg x2) four times daily for 14 day period

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Research Centre, Western General Hospital; 🇬🇧 Edinburgh, City Of Edinburgh, United Kingdom