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

Abbott

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Placebo Eprosartan mesylate; Drug: Eprosartan Mesylate; Drug: Placebo Eprosartan; Drug: Eprosartan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01631227

M13-385

2010-019432-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 665 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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665 participants in 2 patient groups

Eprosartan

Experimental group

Description:

Eprosartan + Placebo Eprosartan Mesylate

Treatment:

Drug: Eprosartan

Drug: Placebo Eprosartan mesylate

Eprosartan Mesylate

Active Comparator group

Description:

Eprosartan Mesylate + Placebo Eprosartan

Treatment:

Drug: Placebo Eprosartan

Drug: Eprosartan Mesylate