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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
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.
Details
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 665 |
| Start date | 2012-06 |
| Completion | 2013-04 |
Conditions
- Essential Hypertension
Interventions
- Eprosartan
- Eprosartan Mesylate
- Placebo Eprosartan mesylate
- Placebo Eprosartan
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 — 8 weeks
Change from baseline of diastolic blood pressure (DBP), sitting
Countries
Germany, Russia, United Kingdom