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

A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05476354

Enrollment

271

Registered

2022-07-27

Start date

2022-07-05

Completion date

2023-06-13

Last updated

2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DRUGIrbesartan/Amlodipine low

Irbesartan/Amlodipine low once daily for 8 weeks

DRUGIrbesartan/Amlodipine high

Irbesartan/Amlodipine high once daily for 8 weeks

DRUGIrbesartan

Irbesartan once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week8

Secondary

Measure	Time frame
Target blood pressure reach rate	Week 4,8
2.Change from baseline in mean sitting diastolic blood pressure(mmHg)	Week 4,8
Responder rate	Week 4,8
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026