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

July 18, 2014 updated by: Abbott

A Prospective, Randomized Double-blind Parallel Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects With Mild to Moderate Essential Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

665

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12627
        • Site Reference ID/Investigator# 74062
      • Bochum, Germany, 44787
        • Site Reference ID/Investigator# 74066
      • Dresden, Germany, 01067
        • Site Reference ID/Investigator# 74065
      • Dresden, Germany, 01307
        • Site Reference ID/Investigator# 93513
      • Essen, Germany, 45355
        • Site Reference ID/Investigator# 93495
      • Frankfurt, Germany, 60594
        • Site Reference ID/Investigator# 93515
      • Frankfurt, Germany, 60596
        • Site Reference ID/Investigator# 74060
      • Goerlitz, Germany, 02826
        • Site Reference ID/Investigator# 74063
      • Hamburg, Germany, 22143
        • Site Reference ID/Investigator# 93494
      • Karlsruhe, Germany, 76199
        • Site Reference ID/Investigator# 93493
      • Leipzig, Germany, 04103
        • Site Reference ID/Investigator# 74061
      • Magdeburg, Germany, 39104
        • Site Reference ID/Investigator# 74064
      • Nuremberg, Germany, 90402
        • Site Reference ID/Investigator# 93514
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • Site reference ID/Investigator # 82515
      • Kazan, Russian Federation, 420012
        • Site reference ID/Investigator # 82520
      • Kemerovo, Russian Federation, 650002
        • Site reference ID/Investigator # 82493
      • Kemerovo, Russian Federation, 650055
        • Site reference ID/Investigator # 82516
      • Krasnodar, Russian Federation, 350086
        • Site refernce ID/Investigator # 82521
      • Novosibirsk, Russian Federation, 630008
        • Site reference ID/Investigator # 82495
      • Novosibirsk, Russian Federation, 630047
        • Site reference ID/Investigator # 82494
      • Novosibirsk, Russian Federation, 630068
        • Site reference ID/Investigator # 82525
      • St. Petersburg, Russian Federation, 192283
        • Site reference ID/Investigator # 82522
      • St. Petersburg, Russian Federation, 194044
        • Site reference ID/Investigator # 82517
      • St. Petersburg, Russian Federation, 197022
        • Site reference ID/Investigator # 82524
      • St. Petersburg, Russian Federation, 197022
        • Site reference ID/Investiragor # 82523
      • St. Petersburg, Russian Federation, 198205
        • Site reference ID/Investigator # 82519
      • St. Petersburg, Russian Federation, 198260
        • Site reference ID/Investigator # 82518
      • St. Petersburg, Russian Federation, 199106
        • Site reference ID/Investigator # 82527
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Site Reference ID/Investigator# 74057
      • Cardiff, United Kingdom, CF14 5GJ
        • Site Reference ID/Investigator# 74059
      • Chorley, United Kingdom, PR7 7NA
        • Site Reference ID/Investigator# 74056
      • Glasgow, United Kingdom, G20 0SP
        • Site Reference ID/Investigator# 74054
      • Glasgow, United Kingdom, G45 9AW
        • Site reference ID/Investigator # 95456
      • Liverpool, United Kingdom, L22 0LG
        • Site Reference ID/Investigator# 74053
      • London, United Kingdom, EC1M 6BQ
        • Site reference ID/Investigator # 95457
      • Manchester, United Kingdom, M16 6SX
        • Site Reference ID/Investigator# 74055
      • Northwood, United Kingdom, HA6 2RN
        • Site reference ID/Investigator # 95455
      • Reading, United Kingdom, RG2 0TG
        • Site Reference ID/Investigator# 74058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eprosartan
Eprosartan + Placebo Eprosartan Mesylate
Drug: Eprosartan
Eprosartan 450 mg
Drug: Placebo Eprosartan mesylate
Placebo Eprosartan mesylate
Other Names:
  • Placebo
Active Comparator: Eprosartan Mesylate
Eprosartan Mesylate + Placebo Eprosartan
Drug: Eprosartan Mesylate
Eprosartan mesylate 600 mg
Other Names:
  • ABT-139
  • Teveten
Drug: Placebo Eprosartan
Placebo Eprosartan
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline
Time Frame: 8 weeks
Change from baseline of diastolic blood pressure (DBP), sitting
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Quintiles, Inc.
Synexus
author! et al. BV

Investigators

  • Study Director: Dmitri N. Kazei, MD, Abbott Healthcare Products B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-385
  • 2010-019432-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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