Essential HypertensionPhase 3NCT01631227

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

A Phase 3 study testing Eprosartan and Eprosartan Mesylate in people with Essential Hypertension, run by Abbott at 38 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Essential Hypertension
What is being tested?: Eprosartan and Eprosartan Mesylate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 665 participants
Where: 38 sitesin 3 countries
Study dates: Jun 2012to Apr 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%)

Trial locations and contacts

38 sites in 3 countries.

Country

City, postcode or hospital

38 sites in 3 countries

Russia15 sites

Site reference ID/Investigator # 82515
Barnaul, 656055
Site reference ID/Investigator # 82520
Kazan', 420012
Site reference ID/Investigator # 82493
Kemerovo, 650002
Site reference ID/Investigator # 82516
Kemerovo, 650055
Site refernce ID/Investigator # 82521
Krasnodar, 350086
Site reference ID/Investigator # 82495
Novosibirsk, 630008
Site reference ID/Investigator # 82494
Novosibirsk, 630047
Site reference ID/Investigator # 82525
Novosibirsk, 630068
Site reference ID/Investigator # 82522
Saint Petersburg, 192283
Site reference ID/Investigator # 82517
Saint Petersburg, 194044
Site reference ID/Investigator # 82524
Saint Petersburg, 197022
Site reference ID/Investiragor # 82523
Saint Petersburg, 197022
Site reference ID/Investigator # 82519
Saint Petersburg, 198205
Site reference ID/Investigator # 82518
Saint Petersburg, 198260
Site reference ID/Investigator # 82527
Saint Petersburg, 199106

Other trials in Russia

Germany13 sites

Site Reference ID/Investigator# 74062
Berlin, 12627
Site Reference ID/Investigator# 74066
Bochum, 44787
Site Reference ID/Investigator# 74065
Dresden, 01067
Site Reference ID/Investigator# 93513
Dresden, 01307
Site Reference ID/Investigator# 93495
Essen, 45355
Site Reference ID/Investigator# 93515
Frankfurt, 60594
Site Reference ID/Investigator# 74060
Frankfurt, 60596
Site Reference ID/Investigator# 74063
Görlitz, 02826
Site Reference ID/Investigator# 93494
Hamburg, 22143
Site Reference ID/Investigator# 93493
Karlsruhe, 76199
Site Reference ID/Investigator# 74061
Leipzig, 04103
Site Reference ID/Investigator# 74064
Magdeburg, 39104
Site Reference ID/Investigator# 93514
Nuremberg, 90402

Other trials in Germany

United Kingdom10 sites

Site Reference ID/Investigator# 74057
Birmingham, B15 2SQ
Site Reference ID/Investigator# 74059
Cardiff, CF14 5GJ
Site Reference ID/Investigator# 74056
Chorley, PR7 7NA
Site Reference ID/Investigator# 74054
Glasgow, G20 0SP
Site reference ID/Investigator # 95456
Glasgow, G45 9AW
Site Reference ID/Investigator# 74053
Liverpool, L22 0LG
Site reference ID/Investigator # 95457
London, EC1M 6BQ
Site Reference ID/Investigator# 74055
Manchester, M16 6SX
Site reference ID/Investigator # 95455
Northwood, HA6 2RN
Site Reference ID/Investigator# 74058
Reading, RG2 0TG

Other trials in United Kingdom

About this study

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

Conditions: Essential Hypertension
Being tested: Eprosartan, Eprosartan Mesylate, Placebo Eprosartan mesylate, Placebo Eprosartan
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EprosartanDrug
Eprosartan 450 mg
Eprosartan MesylateDrug
Also called ABT-139, Teveten
Eprosartan mesylate 600 mg
Placebo Eprosartan mesylateDrug
Also called Placebo
Placebo Eprosartan mesylate
Placebo EprosartanDrug
Also called Placebo
Placebo Eprosartan

Study groups in NCT01631227
Study group	Role	What they receive
Eprosartan	Experimental	Eprosartan + Placebo Eprosartan Mesylate Receives: Drug: Eprosartan; Drug: Placebo Eprosartan mesylate
Eprosartan Mesylate	Active comparator	Eprosartan Mesylate + Placebo Eprosartan Receives: Drug: Eprosartan Mesylate; Drug: Placebo Eprosartan

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Apr 2013

First posted29 Jun 2012 (estimated)
Study startJun 2012
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 665 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01631227
Sponsor's protocol ID: M13-385
Other IDs: 2010-019432-12
Status last verified: Jul 2014
First submitted: 27 Jun 2012
Last updated: 25 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01631227
Acronym / sponsor ID: M13-385
Conditions: Essential Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 665 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc., Synexus, author! et al. BV
Study start: Jun 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 29 Jun 2012 (estimated)
Results: Posted 26 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Eprosartan	Experimental	Drug: Eprosartan, Drug: Placebo Eprosartan mesylateEprosartan + Placebo Eprosartan Mesylate
Eprosartan Mesylate	Active comparator	Drug: Eprosartan Mesylate, Drug: Placebo EprosartanEprosartan Mesylate + Placebo Eprosartan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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%)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EprosartanEprosartan 450 mg	Drug	Eprosartan
Eprosartan MesylateAlso: ABT-139, TevetenEprosartan mesylate 600 mg	Drug	Eprosartan Mesylate
Placebo Eprosartan mesylateAlso: PlaceboPlacebo Eprosartan mesylate	Drug	Eprosartan
Placebo EprosartanAlso: PlaceboPlacebo Eprosartan	Drug	Eprosartan Mesylate

Primary outcome

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
Time frame: 8 weeks
Change from baseline of diastolic blood pressure (DBP), sitting

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eprosartan	333	303
Eprosartan Mesylate	332	310

Primary outcome: 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

Time frame: 8 weeks. Least squares mean (Standard Deviation). Unit: mmHg

Measure	Eprosartan n = 330	Eprosartan Mesylate n = 331
Value	-7.4 (7.7)	-7.2 (7.5)

Population analysed: Full analysis subject sample

Adverse events

Time frame: 15 weeks (3 run-in and 12 weeks treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eprosartan	3 of 332 (0.9%)	15 of 332 (4.5%)	Not reported
Eprosartan Mesylate	7 of 332 (2.1%)	18 of 332 (5.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dmitri N. Kazei, MD study director

Abbott Healthcare Products B.V.

38 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eprosartan and Eprosartan Mesylate in people with Essential Hypertension, run by Abbott at 38 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Russia, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01631227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.