Low-dose Quadruple Combination Therapy in Patients With Hypertension
Condition: Hypertension; Arterial Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Quadruple combination of half doses therapy→Dual combination of standard dose therapy; Dual combination of standard dose therapy→ Quadruple combination of half doses therapy
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2×2 crossover design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; combination therapy; low dose; randomized controlled trial; crossover design