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Completed

NCT Number: NCT01631227

Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in 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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 74062, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Eprosartan

Drug

Eprosartan 450 mg

Eprosartan Mesylate

Drug

Eprosartan mesylate 600 mg

Other names: ABT-139, Teveten

Placebo Eprosartan mesylate

Drug

Placebo Eprosartan mesylate

Other names: Placebo

Placebo Eprosartan

Drug

Placebo Eprosartan

Other names: Placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Quintiles, Inc.
  • Synexus
  • author! et al. BV

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2012
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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