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

Handok

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Irbesartan/Amlodipine high; Drug: Irbesartan; Drug: Irbesartan/Amlodipine low

Study type: Interventional

Funder types: Industry

Identifiers

NCT05476354

HD-AI-301

Details and patient eligibility

About

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

Enrollment: 271 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 3 patient groups

Irbesartan/Amlodipine low

Experimental group

Treatment:

Drug: Irbesartan/Amlodipine low

Irbesartan/Amlodipine high

Experimental group

Treatment:

Drug: Irbesartan/Amlodipine high

Irbesartan

Active Comparator group

Treatment:

Drug: Irbesartan