HypertensionPhase 2/3EFFORTNCT00829296

Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries

A Phase 2/3 study testing nebivolol and Metoprolol in people with Hypertension and Diabetes, run by University of Chicago at 1 site in United States.

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

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries. Read more about this study

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Diabetes
What is being tested?: nebivolol and Metoprolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Apr 2013
Phase: Phase 2/3
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 50 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Established Type 2 diabetic not treated with insulin
Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg
BMI < 35
Hemoglobin A1C < 8.5
Must be postmenopausal or taking some form of birth control of surgically sterile

Who cannot join

Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
Active angina in the last three months
Diabetes requiring treatment with insulin
Severe asthma
Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
Recent history of substance or alcohol abuse .
Uncontrolled hypertension systolic blood pressure >160mmHg or diastolic blood pressure > 100 mmHg

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Read the detailed description

To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Conditions: Hypertension, Diabetes
Being tested: nebivolol, Metoprolol
Keywords: diabetes, hypertension, aortic impedance
Medical subject headings: Hypertension, Diabetes Mellitus

What participants receive

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

nebivololDrug
Also called bystolic
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
MetoprololDrug
Also called lopressor
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Study groups in NCT00829296
Study group	Role	What they receive
nebivolol	Experimental	Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached Receives: Drug: nebivolol
Metoprolol	Active comparator	Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached Receives: Drug: Metoprolol

What is being measured

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

Change in Central Systolic Blood Pressure (SBP)
Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.
Measured: Baseline and 26 Weeks

Secondary outcomes (3)

Change in Pulse Wave Velocity (PWV)
To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.
Measured: Baseline and 26 Weeks
Change in Augmentation Index
Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.
Measured: Baseline and 26 Weeks
Change in Pulse Pressure Amplification
To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).
Measured: Baseline and 26 Weeks

Timeline

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

Jan 2009Apr 2013

First posted27 Jan 2009 (estimated)
Study startJan 2009
Primary completionApr 2012
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 HypertensionStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00829296
Sponsor's protocol ID: 16310B (EFFORT trial)
Acronym: EFFORT
Status last verified: Jan 2016
First submitted: 26 Jan 2009
Last updated: 5 Feb 2016
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

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics
ClinicalTrials.gov ID: NCT00829296
Acronym / sponsor ID: EFFORT / 16310B (EFFORT trial)
Conditions: Hypertension, Diabetes
Keywords: diabetes, hypertension, aortic impedance
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: Jan 2009
Primary completion: Apr 2012 (actual)
Study completion: Apr 2013 (actual)
First posted: 27 Jan 2009 (estimated)
Results: Posted 5 Nov 2014

Clinical summary

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

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Detailed description

To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
nebivolol	Experimental	Drug: nebivololStarting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
Metoprolol	Active comparator	Drug: MetoprololStarting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Established Type 2 diabetic not treated with insulin
Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg
BMI < 35
Hemoglobin A1C < 8.5
Must be postmenopausal or taking some form of birth control of surgically sterile

Key exclusion criteria (7 listed)

Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
Active angina in the last three months
Diabetes requiring treatment with insulin
Severe asthma
Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception

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
nebivololAlso: bystolicStarting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached	Drug	nebivolol
MetoprololAlso: lopressorStarting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached	Drug	Metoprolol

Primary outcome

Change in Central Systolic Blood Pressure (SBP)
Time frame: Baseline and 26 Weeks
Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.

3 secondary outcomes

Change in Pulse Wave Velocity (PWV)
Time frame: Baseline and 26 Weeks
Change in Augmentation Index
Time frame: Baseline and 26 Weeks
Change in Pulse Pressure Amplification
Time frame: Baseline and 26 Weeks

Results and safety

Results posted to the registry on 5 Nov 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
Nebivolol	34	29
Metoprolol	36	32

Primary outcome: Change in Central Systolic Blood Pressure (SBP)

Time frame: Baseline and 26 Weeks. Mean (Standard Deviation). Unit: mmHg

Measure	Nebivolol n = 29	Metoprolol n = 32
Aortic Systolic Blood Pressure at Baseline	125.3 (8.0)	127.8 (8.8)
Aortic Systolic Blood Pressure at 26 Weeks	121.6 (8.2)	123.8 (11.1)

Population analysed: Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 34 (0%)	8 of 34 (23.5%)	Not reported
Metoprolol	0 of 36 (0%)	9 of 36 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
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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.

George Bakris, M.D. principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing nebivolol and Metoprolol in people with Hypertension and Diabetes, run by University of Chicago at 1 site in United States.

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 5 inclusion and 7 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Nov 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?

Change in Central Systolic Blood Pressure (SBP) (time frame: Baseline and 26 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 NCT00829296.

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 5 Feb 2016.