HypertensionPhase 4NCT00673075

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

A Phase 4 study testing Nebivolol and Carvedilol in people with Hypertension and Coronary Artery Disease, run by Forest Laboratories at 34 sites 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

This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension, Coronary Artery Disease
What is being tested?: Nebivolol and Carvedilol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 34 sitesUnited States
Study dates: May 2008to Sep 2009
Phase: Phase 4
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ambulatory outpatients 18 to 85 of age at screening
Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment.
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to exercise stress (treadmill) tests

Who cannot join

Unstable angina within 7 days of screening
Potential coronary surgical/intervention within the next 6 months
Have any form of secondary hypertension
Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Forest Investigator Site
Auburn, Maine, 04210
Forest Investigative Site
Birmingham, Alabama, 35294
Forest Investigative Site
Buena Park, California, 90620
Forest Investigative Site
Carrollton, Texas, 75006
Forest Investigative Site
Charleston, South Carolina, 29401
Forest Investigative Site
Charlotte, North Carolina, 28211
Forest Investigative Site
Chicago, Illinois, 60611
Forest Investigative Site
Cincinnati, Ohio, 45219
Forest Investigative Site
Cleveland, Tennessee, 37312
Forest Investigator Site
Coral Gables, Florida, 33134
Forest Investigative Site
Daytona Beach, Florida, 32117
Forest Investigative Site
Detroit, Michigan, 48202
Forest Investigative Site
Fargo, North Dakota, 58103
Forest Investigator Site
Florence, South Carolina, 29501
Forest Investigative Site
Guilford, Connecticut, 06437
Forest Investigator Site
Hollywood, Florida, 33021
Forest Investigator Site
Indianapolis, Indiana, 46254
Forest Investigator Site
Lafayette, Louisiana, 70503
Forest Investigative Site
Lancaster, Pennsylvania, 17603
Forest Investigative Site
Lansing, Michigan, 48910
Forest Investigator Site
Las Vegas, Nevada, 89119
Forest Investigator Site
Lenoir, North Carolina, 28645
Forest Investigative Site
Los Angeles, California, 90048
Forest Investigator Site
New Smyrna Beach, Florida, 32168
Forest Investigative Site
Northport, New York, 11768
Forest Investigative Site
Orange, California, 92868
Forest Investigative Site
Orlando, Florida, 32803
Forest Investigative Site
Peoria, Arizona, 85381
Forest Investigative Site
Pittsfield, Massachusetts, 01201
Forest Investigator Site
Santa Ana, California, 92705
Forest Investigative Site
The Bronx, New York, 10451
Forest Investigative Site
The Bronx, New York, 10468
Forest Investigator Site
Winter Haven, Florida, 33880
Forest Investigator Site
Worcester, Massachusetts, 01655

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About this study

Official title: Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension

Conditions: Hypertension, Coronary Artery Disease
Being tested: Nebivolol, Carvedilol
Keywords: carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)
Medical subject headings: Hypertension, Coronary Artery Disease

What participants receive

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

NebivololDrug
Also called Bystolic
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
CarvedilolDrug
Also called Coreg
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Study groups in NCT00673075
Study group	Role	What they receive
1	Active comparator	Encapsulated Nebivolol Receives: Drug: Nebivolol
2	Active comparator	Encapsulated Carvedilol Receives: Drug: Carvedilol

What is being measured

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

Peripheral Diastolic Blood Pressure (DBP)
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)
Measured: 18 weeks post initiation of randomized treatment

Secondary outcomes (3)

Peripheral Systolic Blood Pressure (SBP)
Peripheral systolic blood pressure (SBP) at visit 13 (week 18)
Measured: 18 weeks post initiation of randomized treatment
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Measured: 18 weeks post-treatment
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
Left ventricular ejection fraction (LVEF) (%) at Week 18
Measured: 18 weeks post-treatment

Timeline

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

May 2008Sep 2009

First posted7 May 2008 (estimated)
Study startMay 2008
Primary completionSep 2009

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673075
Sponsor's protocol ID: NEB-MD-06
Status last verified: Sep 2010
First submitted: 29 Apr 2008
Last updated: 28 Sep 2010
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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension
ClinicalTrials.gov ID: NCT00673075
Acronym / sponsor ID: NEB-MD-06
Conditions: Hypertension, Coronary Artery Disease
Keywords: carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Sep 2009 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 28 Sep 2010

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: NebivololEncapsulated Nebivolol
2	Active comparator	Drug: CarvedilolEncapsulated Carvedilol

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female ambulatory outpatients 18 to 85 of age at screening
Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment.
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to exercise stress (treadmill) tests

Key exclusion criteria (4 listed)

Unstable angina within 7 days of screening
Potential coronary surgical/intervention within the next 6 months
Have any form of secondary hypertension
Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker

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: BystolicEncapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily	Drug	1
CarvedilolAlso: CoregEncapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily	Drug	2

Primary outcome

Peripheral Diastolic Blood Pressure (DBP)
Time frame: 18 weeks post initiation of randomized treatment
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

3 secondary outcomes

Peripheral Systolic Blood Pressure (SBP)
Time frame: 18 weeks post initiation of randomized treatment
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Time frame: 18 weeks post-treatment
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
Time frame: 18 weeks post-treatment

Results and safety

Results posted to the registry on 28 Sep 2010, 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	21	12
Carvedilol	18	11

Primary outcome: Peripheral Diastolic Blood Pressure (DBP)

Time frame: 18 weeks post initiation of randomized treatment. Mean (Standard Error). Unit: mmHg

Measure	Nebivolol n = 13	Carvedilol n = 12
Baseline	81.1 (1.7)	78.2 (1.8)
Post-baseline	78.0 (2.4)	79.3 (2.6)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol Combined Up-Titration and Stable-dose	1 of 21 (4.8%)	9 of 21 (42.9%)	Not reported
Carvedilol Combined Up-Titration and Stable-dose	0 of 18 (0%)	10 of 18 (55.6%)	Not reported
Nebivolol Down-Titration	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Carvedilol Down-Titration	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early because of difficulties with enrollment. Only 39 out of 160 planned patients were randomized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Tatjana Lukic, MD., M.Sc study director

Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebivolol and Carvedilol in people with Hypertension and Coronary Artery Disease, run by Forest Laboratories at 34 sites 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 4 inclusion and 4 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 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 28 Sep 2010). 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?

Peripheral Diastolic Blood Pressure (DBP) (time frame: 18 weeks post initiation of randomized treatment). 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 NCT00673075.

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 28 Sep 2010.