HypertensionPhase 4NEB-MD-20NCT01057251

Nebivolol in Patients With Systolic Stage 2 Hypertension

A Phase 4 study testing Nebivolol in people with Hypertension, run by Forest Laboratories at 36 sites in United States.

Completed

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

Trial summary

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension. Read more about this study

Who is it for?: Ages 18 to 64 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: 433 participants
Where: 36 sitesUnited States
Study dates: Mar 2010to Jan 2011
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

male of female, 18 to 64 years of age at screening
mean seated heart rate at least 60 bpm
diagnosed systolic stage 2 hypertension
unremarkable physical exam findings

Who cannot join

high risk due to secondary hypertension or former stage 3 hypertension by JNC6
concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
currently taking medication that cannot be stopped during the course of the study
participating other clinical trials
member of the study center personnel
documented drug abuse

Show all 10Show fewer

contra indication to beta blocker
abnormal lab finding
poor compliance
other conditions judged by investigator that is not suitable for the study

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Forest Investigative Site 009
Atlanta, Georgia, 30338
Forest Investigative Site 007
Auburn, Maine, 04210
Forest Investigative Site 031
Augusta, Georgia, 30904
Forest Investigative Site 038
Baltimore, Maryland, 21204
Forest Investigative Site 011
Baltimore, Maryland, 21209
Forest Investigative Site 013
Charleston, South Carolina, 29407
Forest Investigative Site 006
Chino, California, 91710
Forest Investigative Site 028
Coral Gables, Florida, 33134
Forest Investigative Site 032
Corpus Christi, Texas, 78404
Forest Investigative Site 014
Daytona Beach, Florida, 32114
Forest Investigative Site 005
Florissant, Missouri, 63033
Forest Investigative Site 008
Foley, Alabama, 36535
Forest Investigative Site 001
Fort Lauderdale, Florida, 33308
Forest Investigative Site 037
Fort Lauderdale, Florida, 33316
Forest Investigative Site 035
Greenville, South Carolina, 29605
Forest Investigative Site 024
Harleysville, Pennsylvania, 19438
Forest Investigative Site 033
Hialeah, Florida, 33012
Forest Investigative Site 012
Hickory, North Carolina, 28601
Forest Investigative Site 026
Jacksonville, Florida, 32216
Forest Investigative Site 041
Las Vegas, Nevada, 89106
Forest Investigative Site 002
Long Beach, California, 90806
Forest Investigative Site 004
Los Angeles, California, 90057
Forest Investigative Site 003
Memphis, Tennessee, 38119
Forest Investigative Site 039
Meridian, Idaho, 83646
Forest Investigative Site 017
Miami, Florida, 33133
Forest Investigative Site 010
Miami, Florida, 33169
Forest Investigative Site 021
Montgomery, Alabama, 36117
Forest Investigative Site 018
Mt. Pleasant, South Carolina, 29464
Forest Investigative Site 040
New York, New York, 10010
Forest Investigative Site 030
Orlando, Florida, 32806
Forest Investigative Site 023
Paw Paw, Michigan, 49079
Forest Investigative Site 029
Prince Frederick, Maryland, 20678
Forest Investigative Site 025
Richmond, Virginia, 23219
Forest Investigative Site 027
Salisbury, North Carolina, 28144
Forest Investigative Site 022
Simpsonville, South Carolina, 29681
Forest Investigative Site 020
Temecula, California, 92591

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Conditions: Hypertension
Being tested: Nebivolol, Placebo
Keywords: Nebivolol, Bystolic TM, Hypertension, Stage 2 Hypertension
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
5 mg, titrated to 20 mg, once daily oral administration
PlaceboDrug
5 mg or 20 mg once daily, oral administration

Study groups in NCT01057251
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Nebivolol
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Measured: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Measured: Change from Baseline (Week 0) to Visit 4 (Week 6)

Timeline

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

Mar 2010Jan 2011

First posted27 Jan 2010 (estimated)
Study startMar 2010
Primary completionDec 2010
Study completionJan 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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: 433 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01057251
Sponsor's protocol ID: NEB-MD-20
Acronym: NEB-MD-20
Status last verified: Dec 2011
First submitted: 26 Jan 2010
Last updated: 11 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.
PubMed 23332366

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 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension
ClinicalTrials.gov ID: NCT01057251
Acronym / sponsor ID: NEB-MD-20 / NEB-MD-20
Conditions: Hypertension
Keywords: Nebivolol, Bystolic TM, Hypertension, Stage 2 Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 433 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Dec 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 27 Jan 2010 (estimated)
Results: Posted 11 Jan 2012

Clinical summary

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

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Nebivolol
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

male of female, 18 to 64 years of age at screening
mean seated heart rate at least 60 bpm
diagnosed systolic stage 2 hypertension
unremarkable physical exam findings

Key exclusion criteria (10 listed)

high risk due to secondary hypertension or former stage 3 hypertension by JNC6
concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
currently taking medication that cannot be stopped during the course of the study
participating other clinical trials
member of the study center personnel

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: Bystolic5 mg, titrated to 20 mg, once daily oral administration	Drug	1
Placebo5 mg or 20 mg once daily, oral administration	Drug	2

Primary outcome

Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Time frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Time frame: Change from Baseline (Week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.

Results and safety

Results posted to the registry on 11 Jan 2012, 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	290	262
Placebo	143	114

Primary outcome: Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy

Time frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6). Mean (Standard Deviation). Unit: mm Hg

Measure	Nebivolol n = 288	Placebo n = 139
Value	-18.2 (16.7)	-12.3 (17.7)

Primary outcome: Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy

Time frame: Change from Baseline (Week 0) to Visit 4 (Week 6). Mean (Standard Deviation). Unit: mm Hg

Measure	Nebivolol n = 288	Placebo n = 139
Value	-12.3 (9.8)	-5.7 (11.4)

Adverse events

Time frame: Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	1 of 290 (0.3%)	0 of 290 (0%)	Not reported
Placebo	3 of 142 (2.1%)	0 of 142 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23332366Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.

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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)
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.

Manfred Stapff, MD, PhD study director

Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

36 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 36 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 10 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 11 Jan 2012). 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 From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy (time frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)). The study lists 2 primary outcomes in all. 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 NCT01057251, which also lists 1 linked publication.

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 11 Jan 2012.