HypertensionPhase 4NCT00734630

Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

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

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan. Read more about this study

Who is it for?: Ages 18 to 85 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: 491 participants
Where: 75 sitesUnited States
Study dates: Aug 2008to May 2010
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ambulatory outpatients 18-85 years old at screening
Have a history of hypertension
Qualifying laboratory results

Who cannot join

Severe hypertension, including chronic kidney disease
Documented congestive heart failure
Have clinically significant respiratory, liver, or heart disease
History of stroke, heart attack, or heart surgery in the last 6 months
Have a history of hypersensitivity to nebivolol or other beta blockers.

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

United States75 sites

Forest Investigative Site 050
Addison, Illinois, 60101
Forest Investigative Site 024
Anaheim, California, 92801
Forest Investigative Site 080
Ashland, Oregon, 97520
Forest Investigative Site 029
Atlanta, Georgia, 30338
Forest Investigative Site 037
Auburn, Maine, 04210
Forest Investigative Site 012
Bell Gardens, California, 90201
Forest Investigative Site 045
Biddeford, Maine, 04005
Forest Investigative Site 023
Brockton, Massachusetts, 02301
Forest Investigative Site 066
Brockton, Massachusetts, 02301
Forest Investigative Site 046
Brooksville, Florida, 34613
Forest Investigative Site 006
Cary, North Carolina, 27518
Forest Investigative Site 022
Charlotte, North Carolina, 28209
Forest Investigative Site 025
Chicago, Illinois, 60607
Forest Investigative Site 057
Chicago, Illinois, 60611
Forest Investigative Site 026
Chino, California, 91710
Forest Investigative Site 007
Cincinnati, Ohio, 45219
Forest Investigative Site 054
Cleveland, Ohio, 44122
Forest Investigative Site 018
Cleveland, Tennessee, 37312
Forest Investigative Site 008
Corpus Christi, Texas, 78404
Forest Investigative Site 083
Costa Mesa, California, 92626
Forest Investigative Site 068
Decatur, Georgia, 30034
Forest Investigative Site 015
DeLand, Florida, 32720
Forest Investigative Site 051
Edison, New Jersey, 08817
Forest Investigative Site 033
Eugene, Oregon, 97404
Forest Investigative Site 055
Fargo, North Dakota, 58104
Forest Investigative Site 035
Fort Lauderdale, Florida, 33306
Forest Investigative Site 004
Greenville, South Carolina, 29615
Forest Investigative Site 070
Gulf Shores, Alabama, 36535
Forest Investigative Site 081
Harleysville, Pennsylvania, 19438
Forest Investigative Site 064
Harrisburg, North Carolina, 28075
Forest Investigative Site 009
Hialeah, Florida, 33012
Forest Investigative Site 039
Hollywood, Florida, 33021
Forest Investigative Site 092
Huntsville, Alabama, 35801
Forest Investigative Site 044
Jacksonville, Florida, 32223
Forest Investigative Site 076
Joliet, Illinois, 60435
Forest Investigative Site 030
Los Angeles, California, 90057
Forest Investigative Site 043
Memphis, Tennessee, 38819
Forest Investigative Site 058
Mesa, Arizona, 85206
Forest Investigative Site 002
Miami, Florida, 33135
Forest Investigative Site 085
Miami, Florida, 33143
Forest Investigative Site 091
Miami, Florida, 33144
Forest Investigative Site 013
Miami, Florida, 33169
Forest Investigative Site 052
Miami, Florida, 33186
Forest Investigative Site 031
Mt. Pleasant, South Carolina, 29464
Forest Investigative Site 032
Nashville, Tennessee, 37203
Forest Investigative Site 088
New York, New York, 10010
Forest Investigative Site 053
Orange, California, 92868
Forest Investigative Site 014
Orland Park, Illinois, 60467
Forest Investigative Site 049
Orlando, Florida, 32806
Forest Investigative Site 079
Overland Park, Kansas, 66215
Forest Investigative Site 003
Oxon Hill, Maryland, 20745
Forest Investigative Site 065
Pembroke Pines, Florida, 33024
Forest Investigative Site 056
Perrysburg, Ohio, 43551
Forest Investigative Site 060
Prince Frederick, Maryland, 20678
Forest Investigative Site 071
Raleigh, North Carolina, 27612
Forest Investigative Site 042
Reisterstown, Maryland, 21136
Forest Investigative Site 016
Richmond, Virginia, 23294
Forest Investigative Site 077
Riverside, California, 92506
Forest Investigative Site 067
Rolling Fork, Mississippi, 39159
Forest Investigative Site 034
Sacramento, California, 95816
Forest Investigative Site 028
Sacramento, California, 95831
Forest Investigative Site 040
Saint Clair Shores, Michigan, 48081
Forest Investigative Site 063
San Antonio, Texas, 78205
Forest Investigative Site 062
San Antonio, Texas, 78209
Forest Investigative Site 048
San Bernardino, California, 92404
Forest Investigative Site 075
Santa Ana, California, 92705
Forest Investigative Site 087
Santa Ana, California, 92705
Forest Investigative Site 086
Syracuse, New York, 13210
Forest Investigative Site 041
Tampa, Florida, 33603
Forest Investigative Site 090
Temecula, California, 92591
Forest Investigative Site 059
Tempe, Arizona, 85282
Forest Investigative Site 010
Tustin, California, 92780
Forest Investigative Site 001
Westlake Village, California, 91361
Forest Investigative Site 061
Wheat Ridge, Colorado, 80033
Forest Investigative Site 017
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Conditions: Hypertension
Being tested: nebivolol, Placebo
Keywords: nebivolol, Bystolic ™, lisinopril, losartan, 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 ™
Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
PlaceboDrug
Also called Lisinopril-other names: Prinivil, Zestril, Losartan-other name: Cozaar
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Study groups in NCT00734630
Study group	Role	What they receive
Nebivolol	Active comparator	Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg 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.

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).
Measured: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Secondary outcomes (1)

Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Measured: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Timeline

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

Aug 2008May 2010

First posted14 Aug 2008 (estimated)
Study startAug 2008
Primary completionMar 2010
Study completionMay 2010

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: 491 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00734630
Sponsor's protocol ID: NEB-MD-11
Status last verified: Mar 2011
First submitted: 13 Aug 2008
Last updated: 26 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.
PubMed 23519546

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 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.
ClinicalTrials.gov ID: NCT00734630
Acronym / sponsor ID: NEB-MD-11
Conditions: Hypertension
Keywords: nebivolol, Bystolic ™, lisinopril, losartan, Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 491 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Mar 2010 (actual)
Study completion: May 2010 (actual)
First posted: 14 Aug 2008 (estimated)
Results: Posted 26 Apr 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 assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

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

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female, ambulatory outpatients 18-85 years old at screening
Have a history of hypertension
Qualifying laboratory results

Key exclusion criteria (5 listed)

Severe hypertension, including chronic kidney disease
Documented congestive heart failure
Have clinically significant respiratory, liver, or heart disease
History of stroke, heart attack, or heart surgery in the last 6 months
Have a history of hypersensitivity to nebivolol or other beta 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 ™Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration	Drug	Nebivolol
PlaceboAlso: Lisinopril-other names: Prinivil, Zestril, Losartan-other name: CozaarLisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration	Drug	Placebo

Primary outcome

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

1 secondary outcome

Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Results and safety

Results posted to the registry on 26 Apr 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	258	229
Placebo	233	200

Primary outcome: Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12

Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12). Mean (Standard Deviation). Unit: mmHG

Measure	Nebivolol n = 256	Placebo n = 232
Value	-10.1 (16.9)	-7.3 (15.9)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	1 of 258 (0.4%)	0 of 258 (0%)	Not reported
Placebo	3 of 233 (1.3%)	0 of 233 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23519546Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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
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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
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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.

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 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 26 Apr 2011. 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 26 Apr 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?

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 (time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 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 NCT00734630, 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 26 Apr 2011.