This study aims to compare the antihypertensive effect of initial treatment with a single capsule containing quadruple combination of half-dose of blood pressure medicines or standard dose dual combination in patients with hypertension.
This is a single-center, randomized, double-blind, crossover trial, planning to enroll 90 patients with grade 1 and 2 hypertension in the Third Xiangya Hospital of Central South University. The participants will be divided into two groups randomly and treated with half-dose quadruple antihypertensive therapy (irbesartan 75mg+ metoprolol 23.75mg+ amlodipine 2.5mg+ indapamide 1.25mg) or with full-dose dual antihypertensive therapy (irbesartan 150mg+ amlodipine 5mg) for four weeks. After washing out with placebo for two weeks, the participants of the two groups will exchange their medication and be treated for another four weeks. The changes of blood pressure (including 24-hour ambulatory blood pressure, office blood pressure, and home blood pressure) and related adverse effects of the two groups will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Quadruple combination of half doses therapy: a single capsule containing quadruple combination of half doses of blood pressure medicines (amlodipine besylate tablet 2.5mg, amlodipine besylate tablet simulator 2.5mg, irbesartan tablets 75mg, irbesartan tablets simulator 75mg, metoprolol succinate sustained-release tablets 23.75mg, indapamide tablets 1.25mg), take orally, one capsule once a day. Dual combination of standard dose therapy: a single capsule containing dual combination of standard dose of blood pressure medicines (amlodipine besylate tablets 2.5mg×2, irbesartan tablets 75mg×2, metoprolol succinate sustained-release tablets simulator 23.75mg, indapamide tablets simulator 1.25mg), take orally, one capsule once a day.
Dual combination of standard dose therapy: a single capsule containing dual combination of standard dose of blood pressure medicines (amlodipine besylate tablets 2.5mg×2, irbesartan tablets 75mg×2, metoprolol succinate sustained-release tablets simulator 23.75mg, indapamide tablets simulator 1.25mg), take orally, one capsule once a day. Quadruple combination of half doses therapy: a single capsule containing quadruple combination of half doses of blood pressure medicines (amlodipine besylate tablet 2.5mg, amlodipine besylate tablet simulator 2.5mg, irbesartan tablets 75mg, irbesartan tablets simulator 75mg, metoprolol succinate sustained-release tablets 23.75mg, indapamide tablets 1.25mg), take orally, one capsule once a day.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Mean systolic blood pressure of 24-hour
The reduction of mean systolic blood pressure of 24-hour in Ambulatory Blood Pressure Monitoring (ABPM) after 4 weeks of medication (from baseline).
Time frame: Four weeks
Mean systolic blood pressure of daytime and night
The reduction of mean systolic blood pressure of daytime and night in ABPM after 4 weeks of medication (from baseline).
Time frame: Four weeks
Mean diastolic blood pressure of 24-hour, daytime and night
The reduction of mean diastolic blood pressure of 24-hour, daytime and night in ABPM after 4 weeks of medication (from baseline).
Time frame: Four weeks
Morning blood pressure surge
The change of morning blood pressure surge in ABPM after 4 weeks of medication (from baseline).
Time frame: Four weeks
Office blood pressure
The reduction of office blood pressure after 4 weeks of medication (from baseline).
Time frame: Four weeks
Home blood pressure
The reduction of home blood pressure after 4 weeks of medication (from baseline).
Time frame: Four weeks
Heart rate
The change in heart rate after 4 weeks of medication (from baseline).
Time frame: Four weeks
Controlled rate of blood pressure
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Controlled rate of blood pressure after 4 weeks of medication (from baseline).
Time frame: Four weeks