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

Blood Pressure Clinical Trial

— PATH-BP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997112
• Other study ID #: PATHBP_2013
• Secondary ID: PG/13/26/3012 8
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Drug:
• Paracetamol

• Placebo oral capsule

Locations

Country	Name	City	State
United Kingdom	Clinical Research Centre, Western General Hospital	Edinburgh	City Of Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic ambulatory blood pressure	Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.	14 days
Secondary	Systolic clinic blood pressure	Difference in systolic clinic BP between the paracetamol and placebo treated groups.	14 days
Secondary	Diastolic ambulatory blood pressure	Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.	14 days