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Compares treatment options for Hypertension
Official title Morning Versus Bedtime Dosing of Antihypertensive Medication
ClinicalTrials.gov ID: NCT05089448
What this study is testing
What is Alisartan, Amlodipine besylate?
Alisartan, Amlodipine besylate is an investigational medicine, given as an once-daily, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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;
You likely can't join if
- Secondary hypertension;
- Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect...
- 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;
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.