The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy

NCT ID: NCT02433119

Last Updated: 2017-04-12

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

PHASE4

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-16

Study Completion Date

2016-09-08

Brief Summary

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A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy

Detailed Description

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Conditions

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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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Amlodipine orotate & Valsartan

Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks

Group Type EXPERIMENTAL

OROSARTAN® 5/160mg

Intervention Type DRUG

Valsartan & Hydrochlorothiazide

Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks

Group Type ACTIVE_COMPARATOR

CODIOVAN® 160/12.5mg

Intervention Type DRUG

Interventions

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OROSARTAN® 5/160mg

Intervention Type DRUG

CODIOVAN® 160/12.5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 19 aged or over
* A patient who was diagnosed with essential hypertension at screening(Visit 1)
* A patient understood objective of this clinical trial and gave their written informed consent voluntarily

Exclusion Criteria

* A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
* A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
* Medical history or evidence of a secondary form of hypertension
* A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ORT_EH_IV

Identifier Type: -

Identifier Source: org_study_id

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