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Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension

NCT ID: NCT01631227

Last Updated: 2014-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

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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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Eprosartan

Eprosartan + Placebo Eprosartan Mesylate

Group Type EXPERIMENTAL

Eprosartan

Intervention Type DRUG

Eprosartan 450 mg

Placebo Eprosartan mesylate

Intervention Type DRUG

Placebo Eprosartan mesylate

Eprosartan Mesylate

Eprosartan Mesylate + Placebo Eprosartan

Group Type ACTIVE_COMPARATOR

Eprosartan Mesylate

Intervention Type DRUG

Eprosartan mesylate 600 mg

Placebo Eprosartan

Intervention Type DRUG

Placebo Eprosartan

Interventions

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Eprosartan

Eprosartan 450 mg

Intervention Type DRUG

Eprosartan Mesylate

Eprosartan mesylate 600 mg

Intervention Type DRUG

Placebo Eprosartan mesylate

Placebo Eprosartan mesylate

Intervention Type DRUG

Placebo Eprosartan

Placebo Eprosartan

Intervention Type DRUG

Other Intervention Names

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ABT-139 Teveten Placebo Placebo

Eligibility Criteria

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Inclusion Criteria

* Males or females with essential hypertension, blood pressure values between 140 mmHg and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic
* Given written informed consent prior to starting the study

Exclusion Criteria

* Women with childbearing potential, breast feeding or pregnant;
* Inability to discontinue all prior antihypertensive medication;
* Secondary hypertension
* Severe hypertension
* Severe diabetes mellitus (HbA1c greater 8.5%)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Synexus

OTHER

Sponsor Role collaborator

author! et al. BV

UNKNOWN

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dmitri N. Kazei, MD

Role: STUDY_DIRECTOR

Abbott Healthcare Products B.V.

Locations

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Site Reference ID/Investigator# 74062

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 74066

Bochum, , Germany

Site Status

Site Reference ID/Investigator# 74065

Dresden, , Germany

Site Status

Site Reference ID/Investigator# 93513

Dresden, , Germany

Site Status

Site Reference ID/Investigator# 93495

Essen, , Germany

Site Status

Site Reference ID/Investigator# 93515

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 74060

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 74063

Görlitz, , Germany

Site Status

Site Reference ID/Investigator# 93494

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 93493

Karlsruhe, , Germany

Site Status

Site Reference ID/Investigator# 74061

Leipzig, , Germany

Site Status

Site Reference ID/Investigator# 74064

Magdeburg, , Germany

Site Status

Site Reference ID/Investigator# 93514

Nuremberg, , Germany

Site Status

Site reference ID/Investigator # 82515

Barnaul, , Russia

Site Status

Site reference ID/Investigator # 82520

Kazan', , Russia

Site Status

Site reference ID/Investigator # 82493

Kemerovo, , Russia

Site Status

Site reference ID/Investigator # 82516

Kemerovo, , Russia

Site Status

Site refernce ID/Investigator # 82521

Krasnodar, , Russia

Site Status

Site reference ID/Investigator # 82495

Novosibirsk, , Russia

Site Status

Site reference ID/Investigator # 82494

Novosibirsk, , Russia

Site Status

Site reference ID/Investigator # 82525

Novosibirsk, , Russia

Site Status

Site reference ID/Investigator # 82522

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 82517

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 82524

Saint Petersburg, , Russia

Site Status

Site reference ID/Investiragor # 82523

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 82519

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 82518

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 82527

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 74057

Birmingham, , United Kingdom

Site Status

Site Reference ID/Investigator# 74059

Cardiff, , United Kingdom

Site Status

Site Reference ID/Investigator# 74056

Chorley, , United Kingdom

Site Status

Site Reference ID/Investigator# 74054

Glasgow, , United Kingdom

Site Status

Site reference ID/Investigator # 95456

Glasgow, , United Kingdom

Site Status

Site Reference ID/Investigator# 74053

Liverpool, , United Kingdom

Site Status

Site reference ID/Investigator # 95457

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 74055

Manchester, , United Kingdom

Site Status

Site reference ID/Investigator # 95455

Northwood, , United Kingdom

Site Status

Site Reference ID/Investigator# 74058

Reading, , United Kingdom

Site Status

Countries

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Germany Russia United Kingdom

Other Identifiers

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2010-019432-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-385

Identifier Type: -

Identifier Source: org_study_id

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