HypertensionPhase 4NCT00785512

A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

A Phase 4 study testing Nebivolol in people with Hypertension, run by Forest Laboratories at 26 sites in United States.

Completed

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

Trial summary

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 26 sitesUnited States
Study dates: Nov 2008to Aug 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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

male and female outpatients 18 to 79 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
meet criteria for stage I or II hypertension
currently not treated, or being treated with no more than two anti-hypertensive medications

Who cannot join

type 1 or type 2 diabetes
secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
treatment with any investigational study drug within 30 days of Screening (Visit 1)
have a history of hypersensitivity to nebivolol or other β-blockers

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Forest Investigative Site
Auburn, Maine, 04210
Forest Investigative Site
Bradenton, Florida, 34203
Forest Investigative Site
Brooksville, Florida, 34613
Forest Investigative Site
Cary, North Carolina, 27518
Forest Investigative Site
Chandler, Arizona, 85225
Forest Investigative Site
Cincinnati, Ohio, 45242
Forest Investigative Site
Dallas, Texas, 75231
Forest Investigative Site
Dallas, Texas, 75234
Forest Investigative Site
DeLand, Florida, 32720
Forest Investigative Site
Hickory, North Carolina, 28601
Forest Investigative Site
Hollywood, Florida, 33021
Forest Investigative Site
Lancaster, Pennsylvania, 17601
Forest Investigative Site
Los Angeles, California, 90057
Forest Investigative Site
Marion, Ohio, 43302
Forest Investigative Site
Miami, Florida, 33014
Forest Investigative Site
Miami, Florida, 33156
Forest Investigative Site
Miami, Florida, 33169
Forest Investigative Site
Mt. Pleasant, South Carolina, 29464
Forest Investigative Site
New Tazewell, Tennessee, 37825
Forest Investigative Site
Pembroke Pines, Florida, 33024
Forest Investigative Site
Phoenix, Arizona, 85050
Forest Investigative Site
Salisbury, North Carolina, 28144
Forest Investigative Site
Simpsonville, South Carolina, 29681
Forest Investigative Site
St. Petersburg, Florida, 33709
Forest Investigative Site
Wilmington, North Carolina, 28401
Forest Investigative Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Conditions: Hypertension
Being tested: Nebivolol, Placebo
Keywords: nebivolol, Bystolic®, Hypertension, blood pressure, withdrawal
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® (nebivolol)
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
PlaceboDrug
Matching placebo tablets, oral administration

Study groups in NCT00785512
Study group	Role	What they receive
1	Active comparator	Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration Receives: Drug: Nebivolol
2	Placebo comparator	Matching placebo tablets, oral administration Receives: Drug: Placebo

What is being measured

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

Trough Sitting Diastolic Blood Pressure
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
Measured: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Secondary outcomes (1)

Trough Sitting Systolic Blood Pressure
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.
Measured: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Timeline

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

Nov 2008Aug 2009

First posted5 Nov 2008 (estimated)
Study startNov 2008
Primary completionAug 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: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00785512
Sponsor's protocol ID: NEB-MD-17
Status last verified: Aug 2010
First submitted: 3 Nov 2008
Last updated: 15 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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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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy
ClinicalTrials.gov ID: NCT00785512
Acronym / sponsor ID: NEB-MD-17
Conditions: Hypertension
Keywords: nebivolol, Bystolic®, Hypertension, blood pressure, withdrawal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Aug 2009 (actual)
First posted: 5 Nov 2008 (estimated)
Results: Posted 15 Sep 2010

Clinical summary

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

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

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 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
2	Placebo comparator	Drug: PlaceboMatching placebo tablets, oral administration

Who may qualify

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

Key inclusion criteria (4 listed)

male and female outpatients 18 to 79 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
meet criteria for stage I or II hypertension
currently not treated, or being treated with no more than two anti-hypertensive medications

Key exclusion criteria (5 listed)

type 1 or type 2 diabetes
secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
treatment with any investigational study drug within 30 days of Screening (Visit 1)
have a history of hypersensitivity to nebivolol or other β-blockers

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® (nebivolol)Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration	Drug	1
PlaceboMatching placebo tablets, oral administration	Drug	2

Primary outcome

Trough Sitting Diastolic Blood Pressure
Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.

1 secondary outcome

Trough Sitting Systolic Blood Pressure
Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Results and safety

Results posted to the registry on 15 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	102	99
Placebo	105	101

Primary outcome: Trough Sitting Diastolic Blood Pressure

Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12). Mean (Standard Deviation). Unit: mm HG

Measure	Nebivolol n = 101	Placebo n = 105
Baseline	81.3 (7.2)	81.1 (7.0)
Change from baseline	1.8 (7.3)	7.7 (8.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-blind Nebivolol	2 of 269 (0.7%)	29 of 269 (10.8%)	Not reported
Nebivolol	0 of 102 (0%)	0 of 102 (0%)	Not reported
Placebo	0 of 105 (0%)	0 of 105 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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, MSc study director

Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

26 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 in people with Hypertension, run by Forest Laboratories at 26 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 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 15 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 26 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. Some participants in this study may receive a placebo. 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 15 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?

Trough Sitting Diastolic Blood Pressure (time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)). 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 NCT00785512.

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 15 Sep 2010.