Completed
HARMONYHellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial
What is being tested
Anti-hypertensive Medication -
+ Anti-hypertensive Medication -
Drug
Who is being recruted
Cardiovascular Diseases
+ Vascular Diseases
+ Hypertension
From 18 to 80 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: April 2012
Summary
Principal SponsorImperial College London
Last updated: March 8, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorImperial College London
Last updated: March 8, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
103 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesVascular DiseasesHypertension
Criteria
2 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months
Individuals with jobs which require night-time shift work
Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time SBP)
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorAnti hypertensive medication in the evening (between 18.00 and 23.00)
Group II
Active ComparatorAntihypertensive medication in the morning(between 06.00 and 11.00)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Aristotle University of Thessaloniki
Thessaloniki, GreeceOpen Aristotle University of Thessaloniki in Google MapsImperial Clinical Trials Unit
London, United KingdomCompleted2 Study Centers