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

Who is this study for? Patients with grade 1 day-night hypertension
What treatments are being studied? Alisartan+Amlodipine besylate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Male or female patients aged 18-70 years old;

• Never treated for hypertension or stopped using antihypertensive drugs for at least 2 weeks;

• In the two screenings,the clinical systolic BP should be in the range of 140-159 mmHg, the diastolic BP \< 100 mmHg;

• The average 24-hour systolic BP ≥130mmHg, daytime systolic BP ≥ 135 mmHg, and nighttime systolic BP ≥ 120 mmHg;

• The average of bilateral brachial-ankle pulse wave velocity ≥14m/s;

• Be willing to participate in the trial, sign the informed consent form, and be able to visit doctors by himself or herself.

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Li Yan, Professor
liyanshcn@163.com
021-64370045
Time Frame
Start Date: 2021-01-28
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 300
Treatments
Active_comparator: The morning dosing group
After randomization, subjects will take alisartan 120 mg (Salubris, Shenzhen, China) once daily at 6:00-10:00. After 8 weeks of treatment, if the 24-hour ambulatory systolic BP remained ≥ 130 mmHg, alisartan will be doubled to 240mg. After 16 weeks of treatment, if the 24-hour ambulatory systolic BP remained ≥ 130 mmHg, amlodipine besylate 2.5 mg (Dawnrays, Suzhou, China) once daily will be added. The whole treatment duration will last for 24 weeks.
Experimental: The bedtime dosing group
After randomization, subjects will take alisartan 120 mg once daily at 20:00-24:00. The follow-up plan is the same as the morning dosing group.
Authors
Related Therapeutic Areas
Sponsors
Leads: Yan Li

This content was sourced from clinicaltrials.gov