RecruitingPhase 4NCT05089448

Morning Versus Bedtime Dosing of Antihypertensive Medication

Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial (Dosing-Time Trial)


Sponsor

Yan Li

Enrollment

300 participants

Start Date

Jan 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Previous studies have shown that elevated nighttime blood pressure (BP) was more closely associated with cardiovascular mortality and morbidity than daytime and clinic BPs. With increasingly advanced technology, not only 24-hour ambulatory but also home BP monitors can be used to evaluate nighttime BP. The validation study of the Omron HEM 9601T showed that the wrist-type home BP monitor could be a suitable and reliable tool for the diagnosis and management of nocturnal hypertension. However, up to now, there is no data on home nighttime BP in Chinese patients and it is unclear if different dosing time would reduce ambulatory and home nighttime BPs differently. The investigators therefore designed a multicenter randomized clinical trial to compare between morning dosing and bedtime dosing of antihypertensive medications in the difference in nighttime, daytime and the 24-h BP reductions evaluated by both ambulatory and home BP monitoring, and in target organ protections.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing whether taking blood pressure medication in the morning versus at bedtime makes a difference in how well it controls blood pressure. Researchers are particularly interested in whether nighttime dosing can better lower blood pressure throughout the day and night. **You may be eligible if...** - You are between 18 and 70 years old - You have high blood pressure (systolic pressure between 140–159 mmHg in the clinic) and have not been on blood pressure medication (or stopped taking it at least 2 weeks ago) - Your 24-hour blood pressure monitor confirms elevated readings - Your artery stiffness measurement is elevated (pulse wave velocity ≥14 m/s) **You may NOT be eligible if...** - Your high blood pressure is caused by another medical condition (secondary hypertension) - You have sleep apnea, insomnia, or nighttime urination problems that affect overnight blood pressure - You have had a heart attack or stroke within the past 6 months - You have atrial fibrillation or frequent abnormal heart rhythms - You need to work night shifts - You have significant liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlisartan, Amlodipine besylate

Drugs will be taken once daily at 6:00-10:00.

DRUGAlisartan, Amlodipine besylate

Drugs will be taken once daily at 20:00-24:00.


Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT05089448


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