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RECRUITING
NCT05089448
PHASE4

Morning Versus Bedtime Dosing of Antihypertensive Medication

Sponsor: Yan Li

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-01-28

Completion Date

2026-09-30

Last Updated

2025-01-06

Healthy Volunteers

No

Interventions

DRUG

Alisartan, Amlodipine besylate

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

DRUG

Alisartan, Amlodipine besylate

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

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China