HypertensionPhase 4NCT01415531

Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

A Phase 4 study testing Nebivolol in people with Hypertension, run by Forest Laboratories at 75 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 purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension. Read more about this study

Who is it for?: Ages 18 to 54 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: 641 participants
Where: 75 sitesUnited States
Study dates: Aug 2011to Apr 2012
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 54 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male and female outpatients, of age 18 - 54 years
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Who cannot join

Secondary hypertension or severe hypertension
History of Type 1 diabetes mellitus
A medical contraindication to discontinuing a current antihypertensive therapy
Clinically significant respiratory disease that prohibit use of a beta blocker

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

United States75 sites

Forest Investigative Site 003
Asheboro, North Carolina, 27203
Forest Investigative Site 009
Atlanta, Georgia, 30084
Forest Investigative Site 025
Augusta, Kansas, 67010
Forest Investigative Site 053
Beaumont, Texas, 77701
Forest Investigative Site 038
Belzoni, Mississippi, 39038
Forest Investigative Site 066
Boerne, Texas, 78006
Forest Investigative Site 019
Brooklyn Center, Minnesota, 55430
Forest Investigative Site 059
Brooksville, Florida, 34601
Forest Investigative Site 049
Buena Park, California, 90620
Forest Investigative Site 034
Burbank, California, 91505
Forest Investigative Site 010
Charlotte, North Carolina, 28277
Forest Investigative Site 017
Chaska, Minnesota, 55318
Forest Investigative Site 007
Chicago, Illinois, 60611
Forest Investigative Site 002
Columbus, Ohio, 43213
Forest Investigative Site 076
Corpus Christi, Texas, 78404
Forest Investigative Site 039
Costa Mesa, California, 92626
Forest Investigative Site 037
Dallas, Texas, 75234
Forest Investigative Site 028
Denver, Colorado, 80220
Forest Investigative Site 056
Downingtown, Pennsylvania, 19335
Forest Investigative Site 014
Elizabeth, New Jersey, 27609
Forest Investigative Site 072
Evansville, Indiana, 47713
Forest Investigative Site 062
Fall River, Massachusetts, 02702
Forest Investigative Site 033
Fort Lauderdale, Florida, 33306
Forest Investigative Site 024
Fountain Valley, California, 92708
Forest Investigative Site 020
Fresno, California, 93726
Forest Investigative Site 021
Fresno, California, 93726
Forest Investigative Site 040
Greenbrae, California, 94904
Forest Investigative Site 006
Hallandale, Florida, 33009
Forest Investigative Site 043
Haltom City, Texas, 84070
Forest Investigative Site 015
Houston, Texas, 77081
Forest Investigative Site 026
Houston, Texas, 77081
Forest Investigative Site 027
Houston, Texas, 77081
Forest Investigative Site 074
Houston, Texas, 77081
Forest Investigative Site 047
La Mesa, California, 91942
Forest Investigative Site 023
Las Vegas, Nevada, 89101
Forest Investigative Site 048
Las Vegas, Nevada, 89101
Forest Investigative Site 052
Las Vegas, Nevada, 89101
Forest Investigative Site 044
Longwood, Florida, 32779
Forest Investigative Site 073
Los Angeles, California, 90057
Forest Investigative Site 029
Louisville, Kentucky, 40213
Forest Investigative Site 008
Lutherville, Maryland, 21093
Forest Investigative Site 068
Madisonville, Kentucky, 42431
Forest Investigative Site 061
Metairie, Louisiana, 70005
Forest Investigative Site 001
Miami, Florida, 33014
Forest Investigative Site 012
Miami, Florida, 33014
Forest Investigative Site 032
Miami, Florida, 33014
Forest Investigative Site 055
Miami, Florida, 33014
Forest Investigative Site 004
Morton, Illinois, 61550
Forest Investigative Site 057
New Orleans, Louisiana, 70119
Forest Investigative Site 058
New Orleans, Louisiana, 70119
Forest Investigative Site 069
Newburgh, Indiana, 47630
Forest Investigative Site 063
Norfolk, Virginia, 23502
Forest Investigative Site 064
Norfolk, Virginia, 23502
Forest Investigative Site 050
Norman, Oklahoma, 73069
Forest Investigative Site 035
Olive Branch, Mississippi, 38654
Forest Investigative Site 071
Orem, Utah, 84058
Forest Investigative Site 045
Oviedo, Florida, 32765
Forest Investigative Site 075
Paw Paw, Michigan, 49079
Forest Investigative Site 022
Pelzer, South Carolina, 29669
Forest Investigative Site 065
Phoenix, Arizona, 85014
Forest Investigative Site 067
Phoenix, Arizona, 85014
Forest Investigative Site 070
Phoenix, Arizona, 85014
Forest Investigative Site 046
Port Orchard, Washington, 98366
Forest Investigative Site 030
Portland, Oregon, 33709
Forest Investigative Site 011
Raleigh, North Carolina, 27609
Forest Investigative Site 016
Raleigh, North Carolina, 27609
Forest Investigative Site 077
Roseville, California, 95661
Forest Investigative Site 060
San Bernardino, California, 92404
Forest Investigative Site 054
San Francisco, California, 94115
Forest Investigative Site 042
Sandy City, Utah, 84070
Forest Investigative Site 018
Spring Valley, California, 91978
Forest Investigative Site 031
St. Petersburg, Florida, 33709
Forest Investigative Site 051
Trenton, New Jersey, 08611
Forest Investigative Site 005
Wilmington, North Carolina, 28401
Forest Investigative Site 036
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

Conditions: Hypertension
Being tested: Nebivolol, Placebo
Keywords: Stage 1, 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
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
PlaceboDrug
Dose-match placebo

Study groups in NCT01415531
Study group	Role	What they receive
1	Experimental	Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration Receives: Drug: Nebivolol
2	Placebo comparator	Dose-matched placebo Receives: Drug: Placebo

What is being measured

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

Trough Seated Diastolic Blood Pressure (DBP)
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Measured: Change from Baseline to Week 8

Secondary outcomes (1)

Trough Seated Systolic Blood Pressure (SBP)
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Measured: Change from Baseline to Week 8

Timeline

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

Aug 2011Apr 2012

First posted12 Aug 2011 (estimated)
Study startAug 2011
Primary completionMar 2012
Study completionApr 2012

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 641 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01415531
Sponsor's protocol ID: NEB-MD-28
Status last verified: Mar 2013
First submitted: 10 Aug 2011
Last updated: 16 May 2013
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 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension
ClinicalTrials.gov ID: NCT01415531
Acronym / sponsor ID: NEB-MD-28
Conditions: Hypertension
Keywords: Stage 1, Stage 2, Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 641 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Mar 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 12 Aug 2011 (estimated)
Results: Posted 16 May 2013

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: NebivololNebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
2	Placebo comparator	Drug: PlaceboDose-matched placebo

Who may qualify

Ages: 18 to 54 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male and female outpatients, of age 18 - 54 years
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Key exclusion criteria (4 listed)

Secondary hypertension or severe hypertension
History of Type 1 diabetes mellitus
A medical contraindication to discontinuing a current antihypertensive therapy
Clinically significant respiratory disease that prohibit use of a 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
NebivololNebivolol (non-trade 5, 10 or 20 mg tablet), oral administration	Drug	1
PlaceboDose-match placebo	Drug	2

Primary outcome

Trough Seated Diastolic Blood Pressure (DBP)
Time frame: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

1 secondary outcome

Trough Seated Systolic Blood Pressure (SBP)
Time frame: Change from Baseline to Week 8

Results and safety

Results posted to the registry on 16 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	214	189
Nebivolol	427	390

Primary outcome: Trough Seated Diastolic Blood Pressure (DBP)

Time frame: Change from Baseline to Week 8. Mean (Standard Deviation). Unit: mmHG

Measure	Placebo n = 211	Nebivolol n = 423
Value	-5.5 (9.5)	-11.8 (8.8)

Placebo vs Nebivolol: Least Squares Mean Difference: -6.3 (95% CI -7.7 to -4.8), p <0.0001, ANCOVA

Population analysed: 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 9 month period from August of 2011 to April of 2012. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 214 (1.9%)	21 of 214 (9.8%)	Not reported
Nebivolol	4 of 427 (0.9%)	37 of 427 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
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
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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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, M. Sc. study director

Forest Laboratories

75 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 75 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 3 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 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 16 May 2013). 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 Seated Diastolic Blood Pressure (DBP) (time frame: Change from Baseline to Week 8). 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 NCT01415531.

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 16 May 2013.