Morning Versus Bedtime Dosing of Antihypertensive Medication

NCT05089448 | Recruiting Phase 4

• 1 other identifier: Dosing-Time Trial20210118
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Nighttime systolic BP reduction in mmHg

  The difference between the morning and bedtime dosing groups in nighttime systolic BP reduction in mmHg measured by the ambulatory BP monitoring after the treatment for 24 weeks

  24 weeks

Secondary Outcomes (9)

• Daytime systolic BP reduction in mmHg, 24-Hour systolic BP reduction in mmHg, Home systolic BP reduction in mmHg

  24 weeks

• Brachial-ankle pulse wave velocity reduction in cm per second

  12 and 24 weeks

• Ambulatory night-to-day BP ratio change in percent; proportions of non-dippers in percent, morning systolic blood pressure in mmHg,

  8 weeks and 24 weeks

• Urinary albumine-to-creatinine ratio change in mg/mmol

  12 weeks and 24 weeks

• change in prevalence of left ventricular hypertrophy defined based on electrocardiogram

  12 weeks and 24 weeks

Study Arms (2)

The morning dosing group

ACTIVE COMPARATOR

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.

Drug: Alisartan, Amlodipine besylate

The bedtime dosing group

EXPERIMENTAL

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.

Drug: Alisartan, Amlodipine besylate

Interventions

Alisartan, Amlodipine besylate DRUG

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

The morning dosing group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Secondary hypertension;
• Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime BP;
• Need to work at night;
• Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
• Concomitant diseases that need taking medications influencing BP;
• Coronary heart disease, myocardial infarction or stroke within recent 6 months;
• Atrial fibrillation or frequent arrhythmia;
• 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;
• Pregnant or lactating women;
• Contraindications of angiotensin II receptor blocker or calcium channel blocker;
• 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.

Sponsors & Collaborators

• Yan Li: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Li Yan, Professor

CONTACT

021-64370045; liyanshcn@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 22, 2021
• Study Start: January 28, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

CN (1)