NCT01631227

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
665

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach
3 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 26, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

June 27, 2012

Results QC Date

April 28, 2014

Last Update Submit

July 18, 2014

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Study Arms (2)

Eprosartan

EXPERIMENTAL

Eprosartan + Placebo Eprosartan Mesylate

Drug: EprosartanDrug: Placebo Eprosartan mesylate

Eprosartan Mesylate

ACTIVE COMPARATOR

Eprosartan Mesylate + Placebo Eprosartan

Drug: Eprosartan MesylateDrug: Placebo Eprosartan

Interventions

EprosartanDRUG

Eprosartan 450 mg

Eprosartan
Eprosartan MesylateDRUG

Eprosartan mesylate 600 mg

Also known as: ABT-139, Teveten
Eprosartan Mesylate
Placebo Eprosartan mesylateDRUG

Placebo Eprosartan mesylate

Also known as: Placebo
Eprosartan
Placebo EprosartanDRUG

Placebo Eprosartan

Also known as: Placebo
Eprosartan Mesylate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Site Reference ID/Investigator# 74062

Berlin, 12627, Germany

Location

Site Reference ID/Investigator# 74066

Bochum, 44787, Germany

Location

Site Reference ID/Investigator# 74065

Dresden, 01067, Germany

Location

Site Reference ID/Investigator# 93513

Dresden, 01307, Germany

Location

Site Reference ID/Investigator# 93495

Essen, 45355, Germany

Location

Site Reference ID/Investigator# 93515

Frankfurt, 60594, Germany

Location

Site Reference ID/Investigator# 74060

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 74063

Görlitz, 02826, Germany

Location

Site Reference ID/Investigator# 93494

Hamburg, 22143, Germany

Location

Site Reference ID/Investigator# 93493

Karlsruhe, 76199, Germany

Location

Site Reference ID/Investigator# 74061

Leipzig, 04103, Germany

Location

Site Reference ID/Investigator# 74064

Magdeburg, 39104, Germany

Location

Site Reference ID/Investigator# 93514

Nuremberg, 90402, Germany

Location

Site reference ID/Investigator # 82515

Barnaul, 656055, Russia

Location

Site reference ID/Investigator # 82520

Kazan', 420012, Russia

Location

Site reference ID/Investigator # 82493

Kemerovo, 650002, Russia

Location

Site reference ID/Investigator # 82516

Kemerovo, 650055, Russia

Location

Site refernce ID/Investigator # 82521

Krasnodar, 350086, Russia

Location

Site reference ID/Investigator # 82495

Novosibirsk, 630008, Russia

Location

Site reference ID/Investigator # 82494

Novosibirsk, 630047, Russia

Location

Site reference ID/Investigator # 82525

Novosibirsk, 630068, Russia

Location

Site reference ID/Investigator # 82522

Saint Petersburg, 192283, Russia

Location

Site reference ID/Investigator # 82517

Saint Petersburg, 194044, Russia

Location

Site reference ID/Investigator # 82524

Saint Petersburg, 197022, Russia

Location

Site reference ID/Investiragor # 82523

Saint Petersburg, 197022, Russia

Location

Site reference ID/Investigator # 82519

Saint Petersburg, 198205, Russia

Location

Site reference ID/Investigator # 82518

Saint Petersburg, 198260, Russia

Location

Site reference ID/Investigator # 82527

Saint Petersburg, 199106, Russia

Location

Site Reference ID/Investigator# 74057

Birmingham, B15 2SQ, United Kingdom

Location

Site Reference ID/Investigator# 74059

Cardiff, CF14 5GJ, United Kingdom

Location

Site Reference ID/Investigator# 74056

Chorley, PR7 7NA, United Kingdom

Location

Site Reference ID/Investigator# 74054

Glasgow, G20 0SP, United Kingdom

Location

Site reference ID/Investigator # 95456

Glasgow, G45 9AW, United Kingdom

Location

Site Reference ID/Investigator# 74053

Liverpool, L22 0LG, United Kingdom

Location

Site reference ID/Investigator # 95457

London, EC1M 6BQ, United Kingdom

Location

Site Reference ID/Investigator# 74055

Manchester, M16 6SX, United Kingdom

Location

Site reference ID/Investigator # 95455

Northwood, HA6 2RN, United Kingdom

Location

Site Reference ID/Investigator# 74058

Reading, RG2 0TG, United Kingdom

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

eprosartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Associate Director Clinical Services
Organization
Abbott
taco.baardman@abbott.com

Study Officials

  • Dmitri N. Kazei, MD

    Abbott Healthcare Products B.V.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 25, 2014

Results First Posted

May 26, 2014

Record last verified: 2014-07

Locations

RU(15)GB(10)DE(13)