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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631227
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : May 26, 2014
Last Update Posted : July 25, 2014
Quintiles, Inc.
author! et al. BV
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Eprosartan Drug: Eprosartan Mesylate Drug: Placebo Eprosartan mesylate Drug: Placebo Eprosartan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Eprosartan
Eprosartan + Placebo Eprosartan Mesylate
Drug: Eprosartan
Eprosartan 450 mg

Drug: Placebo Eprosartan mesylate
Placebo Eprosartan mesylate
Other Name: 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 Name: Placebo

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01631227

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

Responsible Party: Abbott Identifier: NCT01631227     History of Changes
Other Study ID Numbers: M13-385
2010-019432-12 ( EudraCT Number )
First Posted: June 29, 2012    Key Record Dates
Results First Posted: May 26, 2014
Last Update Posted: July 25, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action