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

Phase 1

• Conditions: Hypertension; MedDRA version: 14.1 Level: PT Classification code 10005727 Term: Blood pressure System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: PT Classification code 10005729 Term: Blood pressure ambulatory System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1 Level: PT Classification code 10005756 Term: Blood pressure systolic System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: LLT Classification code 10033762 Term: Paracetamol System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1 Level: PT Classification code 10005735 Term: Blood pressure diastolic System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003204-40-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-04
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

=18 years old, men or post-menopausal women. Half of the patients recruited will be women (to allow PG measurement). Treated hypertensive patients with an average daytime ABPM <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACEi, ARB or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM =135/85 but <150/95.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease. Patients with a 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 NSAIDs, oral anticoagulants or corticosteroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of parcetamol on blood pressure in hypertensives adults taking or not taking antihypertensive medications.;Secondary Objective: Not applicable.;Primary end point(s): Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods. ;Timepoint(s) of evaluation of this end point: Daytime systolic ambulatory BP will be assessed at the start and end of each 14 day period of study drugs.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): i)Difference in clinic systolic BP between paracetamol and placebo periods<br> ii)Difference in daytime diastolic ambulatory BP between paracetamol and placebo periods<br> iii)Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods in patients taking and not taking antihypertensive medications<br><br><br> ;Timepoint(s) of evaluation of this end point: Clinic systolic BP will be assessed on day 0, day 4&7, and day 14 of study drugs. Ambulatory BP will be assessed on day 0 and day 14 (ie start and end of study drugs).