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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

paracetamol 1g (500mg x2) four times daily for 14 day period

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Placebo

Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Interventions

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Paracetamol

Intervention Type DRUG

Placebo oral capsule

Intervention Type DRUG

Other Intervention Names

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Acetaminophen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No