Phase 3
Completed N=665
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
Source: ClinicalTrials.gov NCT01631227 ↗Enrolled (actual)
665
Serious AEs
1.5%
Results posted
May 2014
Primary outcomePrimary: 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 — -7.4; -7.2 mmHg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-7.4; -7.2 | — |
Eligibility 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%)
Data sourced from ClinicalTrials.gov (NCT01631227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.