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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.
 
ClinicalTrials.gov Identifier: NCT01631227
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : May 26, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborators:
Quintiles, Inc.
Synexus
author! et al. BV
Information provided by (Responsible Party):
Abbott

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01631227


Locations
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Sponsors and Collaborators
Abbott
Quintiles, Inc.
Synexus
author! et al. BV
Investigators
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Study Director: Dmitri N. Kazei, MD Abbott Healthcare Products B.V.
More Information
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01631227    
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:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Eprosartan
 Antihypertensive Agents
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action