Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Handok Inc.271 enrolled

Overview

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

271

Conditions

Essential Hypertension

Interventions

Irbesartan/Amlodipine lowDRUG

Irbesartan/Amlodipine low once daily for 8 weeks

Irbesartan/Amlodipine highDRUG

Irbesartan/Amlodipine high once daily for 8 weeks

IrbesartanDRUG

Irbesartan once daily for 8 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are 19 years or older on screening * Signed informed consent * Patients with Essential Hypertension * Other inclusion applied Exclusion Criteria: * Orthostatic hypotension * Other exclusion applied

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline in mean sitting systolic blood pressure(mmHg)

Time frame: Week8

Secondary Outcomes

Change from baseline in mean sitting systolic blood pressure(mmHg)

Time frame: Week 4

2.Change from baseline in mean sitting diastolic blood pressure(mmHg)

Time frame: Week 4,8

Responder rate

Time frame: Week 4,8

Target blood pressure reach rate

Time frame: Week 4,8

Data from ClinicalTrials.gov

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