Trial | NCT01631227  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    eprosartan ...

  • Study Participants

    665
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.
Study Started
Jun 30
2012
Primary Completion
Apr 30
2013
Study Completion
Apr 30
2013
Results Posted
May 26
2014
Estimate
Last Update
Jul 25
2014
Estimate

Drug Eprosartan

Eprosartan 450 mg

Drug Eprosartan Mesylate

Eprosartan mesylate 600 mg

  • Other names: ABT-139, Teveten

Drug Placebo Eprosartan mesylate

Placebo Eprosartan mesylate

  • Other names: Placebo

Drug Placebo Eprosartan

Placebo Eprosartan

  • Other names: Placebo

Eprosartan Experimental

Eprosartan + Placebo Eprosartan Mesylate

Eprosartan Mesylate Active Comparator

Eprosartan Mesylate + Placebo Eprosartan

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%)

Summary

Eprosartan

Eprosartan Mesylate

All Events

Event Type Organ System Event Term Eprosartan Eprosartan Mesylate

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

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

Eprosartan

-7.4
mmHg (Least Squares Mean)
Standard Deviation: 7.7

Eprosartan Mesylate

-7.2
mmHg (Least Squares Mean)
Standard Deviation: 7.5

Total

665
Participants

Age, Continuous

60
years (Mean)
Standard Deviation: 10

Gender

Overall Study

Eprosartan

Eprosartan Mesylate

Drop/Withdrawal Reasons

Eprosartan

Eprosartan Mesylate