Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
ID05089448

Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension A Multicenter Randomized Controlled Trial

Led by Yan Li · Updated on 2025-01-06

300

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how taking antihypertensive medications in the morning versus at bedtime affects blood pressure, especially nighttime blood pressure, in people with grade 1 day-night hypertension. This Phase 4 multicenter randomized controlled trial aims to understand whether the timing of medication can better reduce nighttime, daytime, and 24-hour blood pressure and provide protection to target organs. The study focuses on Chinese patients and uses newly available home blood pressure monitors validated for nighttime measurement. Participants will take medications containing Alisartan and Amlodipine besylate once daily, either in the morning between 6:00 and 10:00 or at bedtime between 20:00 and 24:00. The trial compares these two dosing schedules to see which reduces blood pressure more effectively. The study uses both ambulatory and home blood pressure monitoring to track changes over time. During the 24-week study, participants will be closely monitored with regular blood pressure assessments, including nighttime systolic blood pressure reduction as the main outcome. Researchers will also evaluate daytime and 24-hour blood pressure changes. Participants must be able to visit doctors independently and will undergo multiple screenings and tests to assess blood pressure, arterial stiffness, and organ protection. Safety and adherence will be tracked throughout the study to ensure accurate results and patient well-being.

CONDITIONS

Official Title

Morning Versus Bedtime Dosing of Antihypertensive Medication

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18-70 years old
  • Never treated for hypertension or stopped antihypertensive drugs for at least 2 weeks
  • Clinical systolic blood pressure between 140-159 mmHg and diastolic blood pressure less than 100 mmHg in two screenings
  • Average 24-hour systolic blood pressure 130 mmHg or higher, daytime systolic blood pressure 135 mmHg or higher, and nighttime systolic blood pressure 120 mmHg or higher
  • Average bilateral brachial-ankle pulse wave velocity 14 m/s or higher
  • Willing to participate, sign informed consent, and able to visit doctors independently
Not Eligible

You will not qualify if you...

  • Secondary hypertension
  • Obstructive sleep apnea (STOP-BANG score 5 or higher), insomnia, Parkinson's syndrome, nocturnal polyuria, or other conditions affecting nighttime blood pressure
  • Need to work at night
  • Invalid ambulatory blood pressure monitoring (less than 70% valid readings, fewer than 20 daytime readings or fewer than 7 nighttime readings)
  • Diseases requiring medications that affect blood pressure
  • Coronary heart disease, myocardial infarction, or stroke within the last 6 months
  • Atrial fibrillation or frequent arrhythmia
  • Abnormal liver function (ALT, AST, total bilirubin more than twice the upper normal limit), abnormal kidney function (serum creatinine 176 µmol/L or higher), or abnormal potassium levels (5.5 mmol/L or higher or 3.5 mmol/L or lower)
  • Pregnant or breastfeeding women
  • Contraindications to angiotensin II receptor blockers or calcium channel blockers
  • Other diseases making participation unsuitable, such as thyroid diseases, acute infections, chronic mental diseases, or tumors

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200025

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Research Team

L

Li Yan, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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