Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension

NCT ID: NCT04488978

Last Updated: 2022-06-30

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

PHASE2

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-11-09

Brief Summary

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A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Irbesartan low/Amlodipine low

Irbesartan low \& Amlodipine low, once daily for 8 weeks

Group Type EXPERIMENTAL

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Irbesartan low/Amlodipine high

Irbesartan low \& Amlodipine high, once daily for 8 weeks

Group Type EXPERIMENTAL

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Irbesartan high/Amlodipine low

Irbesartan high \& Amlodipine low, once daily for 8 weeks

Group Type EXPERIMENTAL

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Irbesartan high/Amlodipine high

Irbesartan high \& Amlodipine high, once daily for 8 weeks

Group Type EXPERIMENTAL

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Amlodipine low

Amlodipine low, once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Amlodipine high

Amlodipine high, once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Irbesartan low

Irbesartan low, once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Irbesartan high

Irbesartan high, once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Irbesartan/Amlodipine

Intervention Type DRUG

QID

Interventions

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Irbesartan/Amlodipine

QID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are 19 years or older / 75 years or younger on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria

* Orthostatic hypertension with symptom
* Other exclusion applied
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 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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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AI-C201

Identifier Type: -

Identifier Source: org_study_id

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