search
Back to results

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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eprosartan
Eprosartan Mesylate
Placebo Eprosartan mesylate
Placebo Eprosartan
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Site Reference ID/Investigator# 74062
  • Site Reference ID/Investigator# 74066
  • Site Reference ID/Investigator# 74065
  • Site Reference ID/Investigator# 93513
  • Site Reference ID/Investigator# 93495
  • Site Reference ID/Investigator# 93515
  • Site Reference ID/Investigator# 74060
  • Site Reference ID/Investigator# 74063
  • Site Reference ID/Investigator# 93494
  • Site Reference ID/Investigator# 93493
  • Site Reference ID/Investigator# 74061
  • Site Reference ID/Investigator# 74064
  • Site Reference ID/Investigator# 93514
  • Site reference ID/Investigator # 82515
  • Site reference ID/Investigator # 82520
  • Site reference ID/Investigator # 82493
  • Site reference ID/Investigator # 82516
  • Site refernce ID/Investigator # 82521
  • Site reference ID/Investigator # 82495
  • Site reference ID/Investigator # 82494
  • Site reference ID/Investigator # 82525
  • Site reference ID/Investigator # 82522
  • Site reference ID/Investigator # 82517
  • Site reference ID/Investigator # 82524
  • Site reference ID/Investiragor # 82523
  • Site reference ID/Investigator # 82519
  • Site reference ID/Investigator # 82518
  • Site reference ID/Investigator # 82527
  • Site Reference ID/Investigator# 74057
  • Site Reference ID/Investigator# 74059
  • Site Reference ID/Investigator# 74056
  • Site Reference ID/Investigator# 74054
  • Site reference ID/Investigator # 95456
  • Site Reference ID/Investigator# 74053
  • Site reference ID/Investigator # 95457
  • Site Reference ID/Investigator# 74055
  • Site reference ID/Investigator # 95455
  • Site Reference ID/Investigator# 74058

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eprosartan

Eprosartan Mesylate

Arm Description

Eprosartan + Placebo Eprosartan Mesylate

Eprosartan Mesylate + Placebo Eprosartan

Outcomes

Primary Outcome Measures

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
Change from baseline of diastolic blood pressure (DBP), sitting

Secondary Outcome Measures

Full Information

First Posted
June 27, 2012
Last Updated
July 18, 2014
Sponsor
Abbott
Collaborators
Quintiles, Inc., Synexus, author! et al. BV
search

1. Study Identification

Unique Protocol Identification Number
NCT01631227
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Quintiles, Inc., Synexus, author! et al. BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eprosartan
Arm Type
Experimental
Arm Description
Eprosartan + Placebo Eprosartan Mesylate
Arm Title
Eprosartan Mesylate
Arm Type
Active Comparator
Arm Description
Eprosartan Mesylate + Placebo Eprosartan
Intervention Type
Drug
Intervention Name(s)
Eprosartan
Intervention Description
Eprosartan 450 mg
Intervention Type
Drug
Intervention Name(s)
Eprosartan Mesylate
Other Intervention Name(s)
ABT-139, Teveten
Intervention Description
Eprosartan mesylate 600 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Eprosartan mesylate
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Eprosartan mesylate
Intervention Type
Drug
Intervention Name(s)
Placebo Eprosartan
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Eprosartan
Primary Outcome Measure Information:
Title
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
Description
Change from baseline of diastolic blood pressure (DBP), sitting
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri N. Kazei, MD
Organizational Affiliation
Abbott Healthcare Products B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 74062
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Site Reference ID/Investigator# 74066
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Site Reference ID/Investigator# 74065
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Site Reference ID/Investigator# 93513
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Site Reference ID/Investigator# 93495
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Site Reference ID/Investigator# 93515
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Site Reference ID/Investigator# 74060
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Site Reference ID/Investigator# 74063
City
Goerlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
Site Reference ID/Investigator# 93494
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Site Reference ID/Investigator# 93493
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Site Reference ID/Investigator# 74061
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Site Reference ID/Investigator# 74064
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Site Reference ID/Investigator# 93514
City
Nuremberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Site reference ID/Investigator # 82515
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82520
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82493
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82516
City
Kemerovo
ZIP/Postal Code
650055
Country
Russian Federation
Facility Name
Site refernce ID/Investigator # 82521
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82495
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82494
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82525
City
Novosibirsk
ZIP/Postal Code
630068
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82522
City
St. Petersburg
ZIP/Postal Code
192283
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82517
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82524
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Site reference ID/Investiragor # 82523
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82519
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82518
City
St. Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Site reference ID/Investigator # 82527
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 74057
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74059
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74056
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74054
City
Glasgow
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Site reference ID/Investigator # 95456
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74053
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Site reference ID/Investigator # 95457
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74055
City
Manchester
ZIP/Postal Code
M16 6SX
Country
United Kingdom
Facility Name
Site reference ID/Investigator # 95455
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 74058
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs