Clinical trial NCT01631227: Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
name: Synexus
name: author! et al. BV
First posted: 2012-06-29
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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%)

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 74062
city: Bochum
country: Germany
facility: Site Reference ID/Investigator# 74066
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 74065
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 93513
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 93495
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 93515
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 74060
city: Goerlitz
country: Germany
facility: Site Reference ID/Investigator# 74063
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 93494
city: Karlsruhe
country: Germany
facility: Site Reference ID/Investigator# 93493
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 74061
city: Magdeburg
country: Germany
facility: Site Reference ID/Investigator# 74064
city: Nuremberg
country: Germany
facility: Site Reference ID/Investigator# 93514
city: Barnaul
country: Russian Federation
facility: Site reference ID/Investigator # 82515
city: Kazan
country: Russian Federation
facility: Site reference ID/Investigator # 82520
city: Kemerovo
country: Russian Federation
facility: Site reference ID/Investigator # 82493
city: Kemerovo
country: Russian Federation
facility: Site reference ID/Investigator # 82516
city: Krasnodar
country: Russian Federation
facility: Site refernce ID/Investigator # 82521
city: Novosibirsk
country: Russian Federation
facility: Site reference ID/Investigator # 82495
city: Novosibirsk
country: Russian Federation
facility: Site reference ID/Investigator # 82494
city: Novosibirsk
country: Russian Federation
facility: Site reference ID/Investigator # 82525
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82522
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82517
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82524
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investiragor # 82523
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82519
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82518
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator # 82527
city: Birmingham
country: United Kingdom
facility: Site Reference ID/Investigator# 74057
city: Cardiff
country: United Kingdom
facility: Site Reference ID/Investigator# 74059
city: Chorley
country: United Kingdom
facility: Site Reference ID/Investigator# 74056
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 74054
city: Glasgow
country: United Kingdom
facility: Site reference ID/Investigator # 95456
city: Liverpool
country: United Kingdom
facility: Site Reference ID/Investigator# 74053
city: London
country: United Kingdom
facility: Site reference ID/Investigator # 95457
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 74055
city: Northwood
country: United Kingdom
facility: Site reference ID/Investigator # 95455
city: Reading
country: United Kingdom
facility: Site Reference ID/Investigator# 74058
Study officials:
affiliation: Abbott Healthcare Products B.V.
name: Dmitri N. Kazei, MD
role: STUDY_DIRECTOR
References: