NCT05089448RecruitingPhase 4
Morning Versus Bedtime Dosing of Antihypertensive Medication
Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial (Dosing-Time Trial)
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 27 Sept 2021
- Start date
- 28 Jan 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Yan Li
- Diseases
- High blood pressure
- NCT number
- NCT05089448
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From 28 Jan 2021 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime BP;
- Concomitant diseases that need taking medications influencing BP;
- 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.
Other illness
- Secondary hypertension;
- Coronary heart disease, myocardial infarction or stroke within recent 6 months;
- Atrial fibrillation or frequent arrhythmia;
Lab values
- 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;
- Contraindications of angiotensin II receptor blocker or calcium channel blocker;
Other
- Need to work at night;
- Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.