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

This study has been completed.
Sponsor:
Collaborators:
Quintiles
Synexus
author! et al. BV
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01631227
First received: June 27, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Essential Hypertension
Drug: Eprosartan
Drug: Eprosartan Mesylate
Drug: Placebo Eprosartan mesylate
Drug: Placebo Eprosartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change from baseline of diastolic blood pressure (DBP), sitting


Enrollment: 665
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631227

Locations
Germany
Site Reference ID/Investigator# 74062
Berlin, Germany, 12627
Site Reference ID/Investigator# 74066
Bochum, Germany, 44787
Site Reference ID/Investigator# 93513
Dresden, Germany, 01307
Site Reference ID/Investigator# 74065
Dresden, Germany, 01067
Site Reference ID/Investigator# 93495
Essen, Germany, 45355
Site Reference ID/Investigator# 74060
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 93515
Frankfurt, Germany, 60594
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 # 82494
Novosibirsk, Russian Federation, 630047
Site reference ID/Investigator # 82525
Novosibirsk, Russian Federation, 630068
Site reference ID/Investigator # 82495
Novosibirsk, Russian Federation, 630008
Site reference ID/Investigator # 82517
St. Petersburg, Russian Federation, 194044
Site reference ID/Investigator # 82519
St. Petersburg, Russian Federation, 198205
Site reference ID/Investigator # 82522
St. Petersburg, Russian Federation, 192283
Site reference ID/Investiragor # 82523
St. Petersburg, Russian Federation, 197022
Site reference ID/Investigator # 82524
St. Petersburg, Russian Federation, 197022
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
Abbott
Quintiles
Synexus
author! et al. BV
Investigators
Study Director: Dmitri N. Kazei, MD Abbott Healthcare Products B.V.
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01631227     History of Changes
Other Study ID Numbers: M13-385, 2010-019432-12
Study First Received: June 27, 2012
Results First Received: April 28, 2014
Last Updated: April 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eprosartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014