Morning Versus Bedtime Dosing of Antihypertensive Medication
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYan Li
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Alisartan, Amlodipine besylate
DrugDrugs will be taken once daily at 6:00-10:00.
Alisartan, Amlodipine besylate
DrugDrugs will be taken once daily at 20:00-24:00.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: The morning dosing groupActive comparator 1 intervention
Group B: The bedtime dosing groupExperimental treatment 1 intervention
Trial outcomes
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
Time frame
24 weeksSecondary outcomes
1
Daytime systolic BP reduction in mmHg, 24-Hour systolic BP reduction in mmHg, Home systolic BP reduction in mmHg
The difference between the morning and bedtime dosing groups in the daytime and 24-hour systolic BPs reduction in mmHg measured by the ambulatory BP monitoring and home systolic BP reduction in mmHg after treatment for 24 weeks
Time frame
24 weeks2
Brachial-ankle pulse wave velocity reduction in cm per second
The difference between the morning and bedtime dosing groups in reduction of brachial-ankle pulse wave velocity after treatment for 12 and 24 weeks
Time frame
12 and 24 weeks3
Ambulatory night-to-day BP ratio change in percent; proportions of non-dippers in percent, morning systolic blood pressure in mmHg,
The difference between the morning and bedtime dosing groups in change of Ambulatory night-to-day BP ratio change in percent; proportions of non-dippers in percent, and morning systolic blood pressure in mmHg after treatment for 8 and 24 weeks.
Time frame
8 weeks and 24 weeks4
Urinary albumine-to-creatinine ratio change in mg/mmol
The difference between the morning and bedtime dosing groups in change of microalbumine-to-creatinine ratio in random urine samples after treatment for 12 weeks and 24 weeks
Time frame
12 weeks and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Li
Lead sponsor
Shanghai Institute of Hypertension
Sponsor institution
Source ClinicalTrials.gov