hypertension
Conditions
Interventions
Azilsartan management group in the morning::patients were instructed to take azilsartan in the morning (6:00-10:00), and the medication was adjusted by clinicians according to home blood pressure moni
Olmesartan treatment group in the morning: :patients were instructed to take olmesartan cilexetil in the morning (6:00-10:00), and the medication was adjusted by clinicians according to home blood pre
Azilsartan management group at night:patients are instructed to take azilsartan before bedtime (20:00-0:00), and the medication is adjusted by clinicians according to home blood pressure monitoring an
Olmesartan treatment group at night:patients are instructed to take olmesartan cilexetil before bedtime (20:00-0:00), and the medication is adjusted by clinicians according to home blood pressure moni
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. over 18 years old, adhere to daytime activities and sleep at night; 2. Voluntarily participate in the trial and sign the informed consent form; 3. Patients diagnosed with grade 1 or 2 primary non-scoop hypertension (mean sitting systolic blood pressure (msSBP) = 140mmHg and <180mmHg) at admission, who are not receiving treatment or are receiving antihypertensive drugs; 4. Untreated patients (newly diagnosed primary nonscoop hypertension or have a history of hypertension but have not taken any antihypertensive drugs for at least 4 weeks before screening), at the end of the screening visit and the lead period, on the basis of condition 3, to improve the 24-hour ambulatory blood pressure, must meet at least one of the following criteria: mean awake SBP = 135 mm Hg, mean conscious diastolic blood pressure (DBP) =85 mm Hg, average sleep SBP 120 =mm Hg, sleep DBP average =70 mm Hg; 5. Patients receiving antihypertensive drugs (antihypertensive drugs within 4 weeks before screening), at the end of the introductory visit, on the basis of condition 3, to improve 24-hour ambulatory blood pressure, must meet at least one of the following criteria: mean awake SBP =135 mm Hg, mean distillal blood pressure (DBP) =85 mm Hg, average sleep SBP 120 =mm Hg, sleep DBP average =70 mm Hg; Must comply with msSBP=140mmHg and <180mmHg; 6. Complete ambulatory blood pressure and ambulatory ECG data during hospitalization
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, lactating or have a positive pregnancy test; or the participant or his or her partner cannot guarantee effective contraception during the trial (acceptable contraceptive method: true abstinence; IUDs; barrier contraceptives; Or the partner underwent sterilization. Unacceptable forms of contraception: cyclic abstinence, such as contraception according to calendar, ovulation, symptomatic body temperature); or those who have a birth plan within 6 months after the end of the test; 2. Severe cardiopulmonary insufficiency (including but not limited to the following: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke within 6 months; NYHA class IV heart failure, aortic aneurysm or dissection aneurysm, active myocarditis, severe heart valve disease, atrioventricular block of grade II or above, sick sinus syndrome, bradycardia (heart rate 120%; ) 8. Patients with immunocompromise or abnormal liver function (including but not limited to the following: positive human immunodeficiency virus (HIV), hepatitis C (HCV) or treponemal (TP) antibodies, or positive hepatitis B surface antigen (HBsAg) and HBV DNA =1000 U/mL) 9. Patients with CKD5 stage and hemodialysis or strict salt restriction therapy 10. Gastrointestinal lesions or gastrointestinal surgery that may affect drug absorption or excretion, such as gastrointestinal resection, active gastrointestinal inflammation, ulceration or gastrointestinal bleeding, etc., are evaluated by the investigator and cannot participate in the trial 12. mental or legal incapacity; 13. Those who have participated in any investigational drug trial or participated in any medical device clinical trial and used medical device within the past 4 weeks 14. Sleep disturbance shift work (more than three shifts per month during the participant's normal sleep time) 15. Active glaucoma or use of glaucoma drugs (safety exclusion: hypoten
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour ambulatory blood pressure;Clinic blood pressure;Major adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Home blood pressure;24-hour ambulatory electrocardiogram; blood routine examination;Liver and kidney function;echocardiography; | — |
Countries
China
Contacts
Public ContactZhou xiaoya
Renmin Hospital of Wuhan University
Outcome results
None listed