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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Eprosartan; Drug: Eprosartan Mesylate; Drug: Placebo Eprosartan mesylate; Drug: Placebo Eprosartan

• Registration Number: NCT01631227
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-28
• Results First Submitted QC: 2014-04-28
• Results First Posted: 2014-05-26
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 665

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eprosartan	Placebo Eprosartan mesylate	Eprosartan + Placebo Eprosartan Mesylate
Eprosartan	Eprosartan	Eprosartan + Placebo Eprosartan Mesylate
Eprosartan Mesylate	Placebo Eprosartan	Eprosartan Mesylate + Placebo Eprosartan
Eprosartan Mesylate	Eprosartan Mesylate	Eprosartan Mesylate + Placebo Eprosartan

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (38)

Site Reference ID/Investigator# 74066; 🇩🇪 Bochum, Germany

Site Reference ID/Investigator# 74065; 🇩🇪 Dresden, Germany

Site Reference ID/Investigator# 74062; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 93515; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 93495; 🇩🇪 Essen, Germany

Site Reference ID/Investigator# 93513; 🇩🇪 Dresden, Germany

Site Reference ID/Investigator# 74060; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 93493; 🇩🇪 Karlsruhe, Germany

Site Reference ID/Investigator# 93494; 🇩🇪 Hamburg, Germany

Site Reference ID/Investigator# 74061; 🇩🇪 Leipzig, Germany

Site Reference ID/Investigator# 74064; 🇩🇪 Magdeburg, Germany

Site Reference ID/Investigator# 93514; 🇩🇪 Nuremberg, Germany

Site refernce ID/Investigator # 82521; 🇷🇺 Krasnodar, Russian Federation

Site reference ID/Investigator # 82522; 🇷🇺 St. Petersburg, Russian Federation

Site reference ID/Investigator # 82517; 🇷🇺 St. Petersburg, Russian Federation

Site reference ID/Investigator # 82518; 🇷🇺 St. Petersburg, Russian Federation

Site reference ID/Investigator # 82527; 🇷🇺 St. Petersburg, Russian Federation

Site Reference ID/Investigator# 74057; 🇬🇧 Birmingham, United Kingdom

Site Reference ID/Investigator# 74059; 🇬🇧 Cardiff, United Kingdom

Site Reference ID/Investigator# 74056; 🇬🇧 Chorley, United Kingdom

Site Reference ID/Investigator# 74054; 🇬🇧 Glasgow, United Kingdom

Site reference ID/Investigator # 95456; 🇬🇧 Glasgow, United Kingdom

Site Reference ID/Investigator# 74053; 🇬🇧 Liverpool, United Kingdom

Site reference ID/Investigator # 95457; 🇬🇧 London, United Kingdom

Site Reference ID/Investigator# 74055; 🇬🇧 Manchester, United Kingdom

Site Reference ID/Investigator# 74058; 🇬🇧 Reading, United Kingdom

Site reference ID/Investigator # 95455; 🇬🇧 Northwood, United Kingdom

Site reference ID/Investigator # 82515; 🇷🇺 Barnaul, Russian Federation

Site reference ID/Investigator # 82520; 🇷🇺 Kazan, Russian Federation

Site reference ID/Investigator # 82493; 🇷🇺 Kemerovo, Russian Federation

Site reference ID/Investigator # 82516; 🇷🇺 Kemerovo, Russian Federation

Site reference ID/Investigator # 82495; 🇷🇺 Novosibirsk, Russian Federation

Site reference ID/Investigator # 82494; 🇷🇺 Novosibirsk, Russian Federation

Site reference ID/Investigator # 82525; 🇷🇺 Novosibirsk, Russian Federation

Site reference ID/Investigator # 82524; 🇷🇺 St. Petersburg, Russian Federation

Site reference ID/Investiragor # 82523; 🇷🇺 St. Petersburg, Russian Federation

Site reference ID/Investigator # 82519; 🇷🇺 St. Petersburg, Russian Federation

Site Reference ID/Investigator# 74063; 🇩🇪 Goerlitz, Germany