NCT05089448 Morning Versus Bedtime Dosing of Antihypertensive Medication

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 300 participants in total. It began in 2021-01-28 with a primary completion date of 2026-06-30.

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.

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.

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