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Antihypertensive Medication
Bedtime vs Morning Hypertension Medication for High Blood Pressure
Phase 4
Waitlist Available
Led By Scott R Garrison, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 years
Awards & highlights
Study Summary
This trial is testing whether taking blood pressure lowering medications at bedtime, instead of in the morning, will reduce mortality and cardiovascular morbidity.
Who is the study for?
This trial is for adults with high blood pressure who take daily medication and live at home (assisted living is okay). They must be able to consent and not have glaucoma, use related meds, do shift work that disrupts sleep, or be in palliative care.Check my eligibility
What is being tested?
The study tests if taking blood pressure meds at bedtime instead of morning reduces the risk of heart problems. It's a large-scale test across Canada where patients are randomly assigned to either morning or night medication routines.See study design
What are the potential side effects?
Specific side effects aren't listed but generally, antihypertensive medications can cause dizziness, fatigue, headaches or digestive issues. This trial will monitor all health data to assess any potential harms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Adverse Cardiovascular Events
Secondary outcome measures
Acute coronary syndrome
All-cause hospitalization
All-cause mortality
+6 moreOther outcome measures
Acute care costs
Adherence to medication timing allocation
Falling
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bedtime BP MedsExperimental Treatment1 Intervention
Use of blood pressure lowering medication at bedtime
Group II: Morning BP MedsActive Control1 Intervention
Use of blood pressure lowering medication in the morning
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,341 Previous Clinical Trials
26,449,356 Total Patients Enrolled
University of AlbertaLead Sponsor
886 Previous Clinical Trials
381,421 Total Patients Enrolled
Alberta Innovates Health SolutionsOTHER
52 Previous Clinical Trials
90,888 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your primary care provider believes that you need end-of-life care.You have had glaucoma in the past or currently use medication for glaucoma.You work irregular hours that disrupt your regular sleep schedule.You take at least one blood pressure medication once a day, or your doctor is willing to change one of your blood pressure medications to once a day.
Research Study Groups:
This trial has the following groups:- Group 1: Bedtime BP Meds
- Group 2: Morning BP Meds
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment actively recruiting participants at the moment?
"Clinicaltrials.gov states that this clinical trial is not currently recruiting patients. First published on December 1st 2016, the study was last modified on June 15th 2022. Although it has reached its recruitment goal and ended, there are 746 other trials actively seeking participants at present time."
Answered by AI
Does the FDA recognize bedtime use of blood pressure lowering medications?
"Our team at Power has determined that the use of blood pressure-lowering medication when sleeping is safe, rating it a 3 on our 1 to 3 scale. This treatment has been officially approved following Phase 4 trials."
Answered by AI
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