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

H

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

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

Trial contacts and locations

1

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Central trial contact

SeJin Kim

Data sourced from clinicaltrials.gov

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