HypertensionPhase 3NCT00648895

A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

A Phase 3 study testing Nebivolol and Metoprolol ER (TM) in people with Hypertension, run by Forest Laboratories 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 designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypertension
What is being tested?: Nebivolol and Metoprolol ER (TM)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Jul 2009
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 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Who cannot join

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

Trial locations and contacts

1 site in 1 country.

United States1 site

Forest Investigative Site
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension

Conditions: Hypertension
Being tested: Nebivolol, Metoprolol ER (TM)
Keywords: Hypertension, Blood pressure, Nebivolol, Bystolic (TM), Metoprolol ER (TM)
Medical subject headings: Hypertension

What participants receive

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

NebivololDrug
Also called Bystolic (TM)
nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
Metoprolol ER (TM)Drug
Also called Toprol XL (TM)
Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Study groups in NCT00648895
Study group	Role	What they receive
1	Active comparator	Nebivolol Receives: Drug: Nebivolol
2	Active comparator	Metoprolol ER (TM) Receives: Drug: Metoprolol ER (TM)

What is being measured

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

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).
Measured: Before treatment and after 10 weeks

Timeline

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

Nov 2007Jul 2009

First posted1 Apr 2008 (estimated)
Study startNov 2007
Primary completionJul 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00648895
Sponsor's protocol ID: NEB-MD-08
Status last verified: Aug 2010
First submitted: 28 Mar 2008
Last updated: 20 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?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension
ClinicalTrials.gov ID: NCT00648895
Acronym / sponsor ID: NEB-MD-08
Conditions: Hypertension
Keywords: Hypertension, Blood pressure, Nebivolol, Bystolic (TM), Metoprolol ER (TM)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2009 (actual)
First posted: 1 Apr 2008 (estimated)
Results: Posted 20 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: NebivololNebivolol
2	Active comparator	Drug: Metoprolol ER (TM)Metoprolol ER (TM)

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Key exclusion criteria (5 listed)

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, 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: Bystolic (TM)nebivolol 10mg, 20mg, 40mg daily dosage, oral administration	Drug	1
Metoprolol ER (TM)Also: Toprol XL (TM)Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration	Drug	2

Primary outcome

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
Time frame: Before treatment and after 10 weeks
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).

Results and safety

Results posted to the registry on 20 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	6	6
Metoprolol ER (TM)	6	5

Primary outcome: Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).

Time frame: Before treatment and after 10 weeks. Mean (Standard Deviation). Unit: Percentage

Population analysed: Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.

Adverse events

Time frame: 16 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Metoprolol ER (TM)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early because of difficulties with enrollment. Only 12 of 30 planned patients were enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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Not yet recruitingPhase 2/3
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
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, 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.

Tatjana Lukic, MD., M.Sc. study director

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nebivolol and Metoprolol ER (TM) in people with Hypertension, run by Forest Laboratories 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 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 20 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 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 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 20 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?

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR). (time frame: Before treatment and after 10 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 NCT00648895.

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 20 Sep 2010.