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

NCT ID: NCT05475665

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2023-06-13

Brief Summary

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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

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Irbesartan/Amlodipine

Group Type EXPERIMENTAL

Irbesartan/Amlodipine

Intervention Type DRUG

Irbesartan/Amlodipine once daily for 8 weeks

Irbesartan

Group Type ACTIVE_COMPARATOR

Irbesartan

Intervention Type DRUG

Irbesartan once daily for 8 weeks

Interventions

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Irbesartan/Amlodipine

Irbesartan/Amlodipine once daily for 8 weeks

Intervention Type DRUG

Irbesartan

Irbesartan once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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 with symptom
* Other exclusion applied
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee HY, Min KW, Han KA, Kim JS, Ahn JC, Kim MH, Lee JB, Shin SH, Kim CJ, Kim KH, Cho DK, Choi J, Rhee MY, Her SH, Kim W, Na JO, Cho GY, Kim SY, Park GM, Lee BK, Jo SH, Lee BW, Sohn IS, Kim DI, Ihm SH, Lee SH, Chung JW, Cho EJ, Son JW, Oh SJ, Hwang JY, Jeong JO, Han KR, Yoon HJ, Seo SM, Chung WJ, Bae JW, Choi JH, Hyun BJ, Cha JE, Yoo SJ, Shin J. The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy. Clin Ther. 2024 Jun;46(6):481-489. doi: 10.1016/j.clinthera.2024.04.004. Epub 2024 May 3.

Reference Type DERIVED
PMID: 38704294 (View on PubMed)

Other Identifiers

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HD-AI-302

Identifier Type: -

Identifier Source: org_study_id

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