Morning Versus Bedtime Dosing of Antihypertensive Medication

NCT ID: NCT05089448

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Alisartan, Amlodipine besylate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Alisartan, Amlodipine besylate

Intervention Type: DRUG

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

Interventions

Alisartan, Amlodipine besylate

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

Intervention Type: DRUG

Alisartan, Amlodipine besylate

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged 18-70 years old;

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

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

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

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

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

Exclusion Criteria

1. Secondary hypertension;

2. Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime BP;

3. Need to work at night;

4. Ambulatory BP monitoring was invalid (<70% valid readings, or <20 daytime readings or <7 nighttime readings);

5. Concomitant diseases that need taking medications influencing BP;

6. Coronary heart disease, myocardial infarction or stroke within recent 6 months;

7. Atrial fibrillation or frequent arrhythmia;

8. Abnormal liver function exemplified as an increased alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) over the double of the upper limit of normal range; abnormal renal function exemplified as a serum creatinine ≥176 µmol/L; and plasma potassium ≥5.5 mmol/L or ≤3.5mmol/L;

9. Pregnant or lactating women;

10. Contraindications of angiotensin II receptor blocker or calcium channel blocker;

11. Other concomitant diseases which are considered not suitable to participate in the trial, such as thyroid diseases, acute infectious diseases, chronic mental diseases, tumor, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Li

OTHER

Sponsor Role: lead

Responsible Party

Yan Li

Professor of Cardiovascular Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yan, Professor

Role: CONTACT

liyanshcn@163.com

021-64370045 ext. 663228

Facility Contacts

Yan Li, Professor

Role: primary

liyanshcn@163.com

021-64370045 ext. 663228

Yan Li, Professor

Role: backup

Other Identifiers

Dosing-Time Trial20210118

Identifier Type: -

Identifier Source: org_study_id