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

Abbott665 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

665

Conditions

Essential Hypertension

Interventions

EprosartanDRUG

Eprosartan 450 mg

Eprosartan MesylateDRUG

Eprosartan mesylate 600 mg

Placebo Eprosartan mesylateDRUG

Placebo Eprosartan mesylate

Placebo Eprosartan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%)

Locations (38)

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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Site Reference ID/Investigator# 74062

Berlin, Germany

Site Reference ID/Investigator# 74066

Bochum, Germany

Site Reference ID/Investigator# 74065

Dresden, Germany

Site Reference ID/Investigator# 93513

Dresden, Germany

Site Reference ID/Investigator# 93495

Essen, Germany

Site Reference ID/Investigator# 93515

Frankfurt, Germany

Site Reference ID/Investigator# 74060

Frankfurt, Germany

Site Reference ID/Investigator# 74063

Görlitz, Germany

Site Reference ID/Investigator# 93494

Hamburg, Germany

Site Reference ID/Investigator# 93493

Karlsruhe, Germany

...and 28 more locations