NCT05089448

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Yan Li · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Blood Pressure
• Drug Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-28
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2021-10-22
• Last updated: 2025-01-06

Locations

1 site across 1 country: China