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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Eprosartan
    • Eprosartan 450 mg
  • Drug: Eprosartan Mesylate
    • Eprosartan mesylate 600 mg
  • Drug: Placebo Eprosartan mesylate
    • Placebo Eprosartan mesylate
  • Drug: Placebo Eprosartan
    • Placebo Eprosartan

Arms, Groups and Cohorts

  • Experimental: Eprosartan
    • Eprosartan + Placebo Eprosartan Mesylate
  • Active Comparator: Eprosartan Mesylate
    • Eprosartan Mesylate + Placebo Eprosartan

Clinical Trial Outcome Measures

Primary 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
    • Change from baseline of diastolic blood pressure (DBP), sitting

Participating in This Clinical Trial

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%)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Collaborator
    • Quintiles, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dmitri N. Kazei, MD, Study Director, Abbott Healthcare Products B.V.

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