HypertensionPhase 4NCT00770861

A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

A Phase 4 study testing Nebivolol in people with Hypertension, run by Forest Laboratories at 32 sites in 2 countries.

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 efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension Read more about this study

Who is it for?: Ages 18 to 80 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: 277 participants
Where: 32 sitesin 2 countries
Study dates: Sep 2008to Nov 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 and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
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

Secondary hypertension
Are taking three or more antihypertensive agents
Have uncontrolled or poorly controlled diabetes mellitus type I or type II
Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
Participation in any investigational study within 30 days of Screening (Visit 1).
Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Trial locations and contacts

32 sites in 2 countries.

Country

City, postcode or hospital

32 sites in 2 countries

United States29 sites

Forest Investigative Site
Atlanta, Georgia, 30312
Forest Investigative Site
Atlanta, Georgia, 30338
Forest Investigative Site
Buena Park, California, 90620
Forest Investigative Site
Carrollton, Texas, 75006
Forest Investigative Site
Chino, California, 91710
Forest Investigative Site
Coral Gables, Florida, 33134
Forest Investigative Site
Corpus Christi, Texas, 78404
Forest Investigative Site
Dallas, Texas, 75235
Forest Investigative Site
El Paso, Texas, 79902
Forest Investigative Site FL2
Hialeah, Florida, 33012
Forest Investigative Site
Hialeah, Florida, 33012
Forest Investigative Site
Hialeah, Florida, 33016
Forest Investigative Site
Kissimmee, Florida, 34741
Forest Investigative Site
Long Beach, California, 90806
Forest Investigative Site
Los Angeles, California, 90057
Forest Investigative Site
Miami, Florida, 33014
Forest Investigative Site
Miami, Florida, 33169
Forest Investigative Site
Miami, Florida, 33183
Forest Investigative Site
National City, California, 91950
Forest Investigative Site
New Windsor, New York, 12553
Forest Investigative Site
Pembroke Pines, Florida, 33024
Forest Investigative Site
Pembroke Pines, Florida, 33027
Forest Investigative Site
San Antonio, Texas, 78224
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
San Bernardino, California, 92404
Forest Investigative Site
Temecula, California, 92591
Forest Investigative Site
The Bronx, New York, 10451
Forest Investigative Site
Tustin, California, 92780
Forest Investigative Site
West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico3 sites

Forest Investigative Site
Ponce, 00717
Forest Investigative Site
Salinas, 00751
Forest Investigative Site
Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension

This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

Conditions: Hypertension
Being tested: Nebivolol, Placebo
Keywords: nebivolol, Bystolic ™, Hypertension, Hispanic, Hypertension in Hispanic patients
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 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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 NCT00770861
Study group	Role	What they receive
Nebivolol	Active comparator	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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
Placebo	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.

Change From Baseline in Trough Seated DBP at Week 8(LOCF).
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
Measured: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Secondary outcomes (1)

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.
Measured: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Timeline

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

Sep 2008Nov 2009

First posted10 Oct 2008 (estimated)
Study startSep 2008
Primary completionNov 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: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770861
Sponsor's protocol ID: NEB-MD-16
Status last verified: Dec 2010
First submitted: 9 Oct 2008
Last updated: 26 Jan 2011
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 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00770861
Acronym / sponsor ID: NEB-MD-16
Conditions: Hypertension
Keywords: nebivolol, Bystolic ™, Hypertension, Hispanic, Hypertension in Hispanic patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Nov 2009 (actual)
First posted: 10 Oct 2008 (estimated)
Results: Posted 26 Jan 2011

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 efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or 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
Nebivolol	Active comparator	Drug: NebivololNebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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
Placebo	Placebo comparator	Drug: PlaceboMatching placebo tablets, oral administration

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 and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
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 (6 listed)

Secondary hypertension
Are taking three or more antihypertensive agents
Have uncontrolled or poorly controlled diabetes mellitus type I or type II
Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
Participation in any investigational study within 30 days of Screening (Visit 1).

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 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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	Nebivolol
PlaceboMatching placebo tablets, oral administration	Drug	Placebo

Primary outcome

Change From Baseline in Trough Seated DBP at Week 8(LOCF).
Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.

1 secondary outcome

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Results and safety

Results posted to the registry on 26 Jan 2011, 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	141	131
Placebo	136	120

Primary outcome: Change From Baseline in Trough Seated DBP at Week 8(LOCF).

Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8). Mean (Standard Deviation). Unit: mm Hg

Measure	Nebivolol n = 141	Placebo n = 135
Value	-11.1 (8.8)	-7.3 (8.9)

Nebivolol vs Placebo: p <0.0001, ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 141 (0%)	5 of 141 (3.5%)	Not reported
Placebo	1 of 136 (0.7%)	8 of 136 (5.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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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., M.Sc. study director

Forest Research Institute, a subsidiary of Forest Laboratories Inc.

32 sites in 2 countries: 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 32 sites in 2 countries.

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 6 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Puerto Rico. 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 26 Jan 2011). 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 Trough Seated DBP at Week 8(LOCF). (time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (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 NCT00770861.

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 26 Jan 2011.