Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Anti-hypertensive Medication -

• Registration Number: NCT01669928
• Lead Sponsor: Imperial College London

Brief Summary

A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.

To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

Detailed Description

The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2019-04-29
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Results First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Caucasian patients aged 18-80 years;
• History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

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Exclusion Criteria

• BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months.
• Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
• Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time SBP)
• Individuals with jobs which require night-time shift work.
• Pregnant women or those planning to become pregnant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evening medication	Anti-hypertensive Medication -	Anti hypertensive medication in the evening (between 18.00 and 23.00)
Morning medication	Anti-hypertensive Medication -	Antihypertensive medication in the morning(between 06.00 and 11.00)

Primary Outcome Measures

Name	Time	Method
Changes in 24 Hour Systolic Blood Pressure	6 months	Changes in 24 hour systolic Blood Pressure using ABPM

Secondary Outcome Measures

Name	Time	Method
Mean Clinic - Systolic BP	6 months	This measure was assessed at a clinic.
Mean Clinic - Diastolic BP	6 months	This measure was assessed at a clinic.
Mean Day-time ABPM Systolic BP	6 months
Mean Day-time ABPM Diastolic BP	6 months
Μean Night Time ABPM Diastolic BP	6 months
Quality of Life Score	6 months	Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state.
Μean Night Time ABPM Systolic BP	6 months
Self Reported Side Effects	12 months	Serious Adverse Events reported during the trial

Trial Locations

Locations (2)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Imperial Clinical Trials Unit; 🇬🇧 London, United Kingdom