HypertensionPhase 4NCT00673790

The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

A Phase 4 study testing Nebivolol with concomitant losartan or lisinopril and HCTZ with concomitant losartan or lisinopril in people with Hypertension, run by Forest Laboratories at 88 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients. 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 with concomitant losartan or lisinopril and HCTZ with concomitant losartan or lisinopril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 537 participants
Where: 88 sitesUnited States
Study dates: 15 May 2008to 9 Jul 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ambulatory outpatients 18-80 years old at screening.
Have a history of hypertension and taking up to 2 medications for high blood pressure.
Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion

Who cannot join

Have clinically significant respiratory, liver or cardiovascular disease
Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.

Trial locations and contacts

88 sites in 1 country.

City, postcode or hospital

88 sites in 1 country

United States88 sites

Forest Investigative Site 056
Anaheim, California, 92801
Forest Investigative Site 126
Arlington, Virginia, 22204
Forest Investigative Site 058
Athens, Alabama, 35611
Forest Investigative Site 075
Atlanta, Georgia, 30312
Forest Investigative Site 072
Atlanta, Georgia, 30338
Forest Investigative Site 106
Auburn, Maine, 04210
Forest Investigative Site 042
Augusta, Georgia, 30904
Forest Investigative Site 097
Bell Gardens, California, 90201
Forest Investigative Site 101
Birmingham, Alabama, 35215
Forest Investigative Site 040
Bountiful, Utah, 84010-5174
Forest Investigative Site 067
Brockton, Massachusetts, 02301
Forest Investigative Site 110
Brockton, Massachusetts, 02301
Forest Investigative Site 071
Brooklyn, New York, 11203
Forest Investigative Site 139
Brooksville, Florida, 34601
Forest Investigative Site 026
Buena Park, California, 90620
Forest Investigative Site 147
Buena Park, California, 90620
Forest Investigative Site 003
Carrollton, Texas, 75006-5810
Forest Investigative Site 091
Centerville, Ohio, 45459
Forest Investigative Site 035
Charlotte, North Carolina, 28209
Forest Investigative Site 051
Charlotte, North Carolina, 28262
Forest Investigative Site 082
Chicago, Illinois, 60607
Forest Investigative Site 061
Chino, California, 91710
Forest Investigative Site 089
Cincinnati, Ohio, 45242
Forest Investigative Site 080
Columbia, Missouri, 65212
Forest Investigative Site 098
Columbia, South Carolina, 29201
Forest Investigative Site 103
Coral Gables, Florida, 33134
Forest Investigative Site 108
Costa Mesa, California, 92626
Forest Investigative Site 019
Daytona Beach, Florida, 32117
Forest Investigative Site 010
DeLand, Florida, 32720
Forest Investigative Site 077
Durham, North Carolina, 27704
Forest Investigative Site 146
Elizabeth, New Jersey, 07202
Forest Investigative Site 054
Encinitas, California, 92024
Forest Investigative Site 087
Eugene, Oregon, 97404
Forest Investigative Site 128
Fresno, California, 93703
Forest Investigative Site 115
Greer, South Carolina, 29651
Forest Investigative Site 114
Harleysville, Pennsylvania, 19438
Forest Investigative Site 073
Hialeah, Florida, 33012
Forest Investigative Site 109
Hialeah, Florida, 33012
Forest Investigative Site 036
Hollywood, Florida, 33023
Forest Investigative Site 094
Honolulu, Hawaii, 96814
Forest Investigative Site 116
Houston, Texas, 77074
Forest Investigative Site 127
Huntington Park, California, 90255
Forest Investigative Site 016
Huntsville, Alabama, 35801
Forest Investigative Site 123
Lafayette, Louisiana, 70503
Forest Investigative Site 100
Lenoir, North Carolina, 28645
Forest Investigative Site 030
Long Beach, California, 90806
Forest Investigative Site 085
Los Angeles, California, 90057
Forest Investigative Site 028
Los Angeles, California, 90211
Forest Investigative Site 065
Madisonville, Kentucky, 42431
Forest Investigative Site 95
Meridian, Idaho, 83646
Forest Investigative Site 104
Miami, Florida, 33135
Forest Investigative Site 121
Miami, Florida, 33143
Forest Investigative Site 099
Miami, Florida, 33183
Forest Investigative Site 074
Milford, Connecticut, 06460
Forest Investigative Site 041
Morehead City, North Carolina, 28557
Forest Investigative Site 124
National City, California, 91950
Forest Investigative Site 081
New York, New York, 10001
Forest Investigative Site 120
Odessa, Texas, 79761
Forest Investigative Site 006
Oxon Hill, Maryland, 20745
Forest Investigative Site 018
Paw Paw, Michigan, 49079
Forest Investigative Site 083
Pawtucket, Rhode Island, 02860
Forest Investigative Site 107
Pembroke Pines, Florida, 33024
Forest Investigative Site 122
Perrysburg, Ohio, 43551
Forest Investigative Site 119
Phoenix, Arizona, 85020
Forest Investigative Site 088
Portland, Oregon, 97210
Forest Investigative Site 117
Riverside, California, 92506
Forest Investigative Site 025
Roseville, California, 95661
Forest Investigative Site 017
Sacramento, California, 95821
Forest Investigative Site 021
Saint Clair Shores, Michigan, 48081
Forest Investigative Site 050
Salisbury, North Carolina, 28144
Forest Investigative Site 062
Salt Lake City, Utah, 84102
Forest Investigative Site 093
Salt Lake City, Utah, 84102
Forest Investigative Site 012
San Antonio, Texas, 78229
Forest Investigative Site 068
San Diego, California, 92128
Forest Investigative Site 112
Santa Ana, California, 92705
Forest Investigative Site 105
Simpsonville, South Carolina, 29201
Forest Investigative Site 092
Sioux Falls, South Dakota, 57104
Forest Investigative Site 141
St. Petersburg, Florida, 33709
Forest Investigative Site 048
Sugar Land, Texas, 77479
Forest Investigative Site 140
Tampa, Florida, 33606
Forest Investigative Site 063
Temecula, California, 92591
Forest Investigative Site 078
Tucson, Arizona, 85715
Forest Investigative Site 013
Tustin, California, 92780
Forest Investigative Site 052
Walnut Creek, California, 94598
Forest Investigative Site 130
West Jordan, Utah, 84088
Forest Investigative Site 060
West Palm Beach, Florida, 33401
Forest Investigative Site 125
West Palm Beach, Florida, 33407
Forest Investigative Site 096
Wichita, Kansas, 67203

Other trials in United States

About this study

Official title: Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

Read the detailed description

This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Conditions: Hypertension
Being tested: Nebivolol with concomitant losartan or lisinopril, HCTZ with concomitant losartan or lisinopril, Placebo with concomitant losartan or lisinopril
Keywords: nebivolol, BYSTOLIC ™, hydrochlorothiazide, lisinopril, Prinivil (TM), Zestril (TM), losartan, Cozaar (TM), Impaired Fasting Glucose, Impaired Glucose Tolerance, hypertension
Medical subject headings: Hypertension, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nebivolol with concomitant losartan or lisinoprilDrug
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
HCTZ with concomitant losartan or lisinoprilDrug
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Placebo with concomitant losartan or lisinoprilDrug
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Study groups in NCT00673790
Study group	Role	What they receive
Nebivolol	Active comparator	Nebivolol with concomitant losartan or lisinopril Receives: Drug: Nebivolol with concomitant losartan or lisinopril
Hydrochlorothiazide (HCTZ)	Active comparator	HCTZ with concomitant losartan or lisinopril Receives: Drug: HCTZ with concomitant losartan or lisinopril
Placebo	Placebo comparator	Placebo with concomitant losartan or lisinopril Receives: Drug: Placebo with concomitant losartan or lisinopril

What is being measured

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

Trough Seated Diastolic Blood Pressure
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Measured: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)

Secondary outcomes (1)

Plasma Glucose Level After an Oral Glucose Tolerance Test
Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.
Measured: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)

Timeline

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

15 May 20089 Jul 2010

First posted7 May 2008 (estimated)
Study start15 May 2008
Primary completion9 Jul 2010
Study completion9 Jul 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.
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: 537 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673790
Sponsor's protocol ID: NEB-MD-04
Status last verified: Feb 2020
First submitted: 29 Apr 2008
Last updated: 26 Feb 2020
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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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
ClinicalTrials.gov ID: NCT00673790
Acronym / sponsor ID: NEB-MD-04
Conditions: Hypertension
Keywords: nebivolol, BYSTOLIC ™, hydrochlorothiazide, lisinopril, Prinivil (TM), Zestril (TM), losartan, Cozaar (TM)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 537 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 15 May 2008 (actual)
Primary completion: 9 Jul 2010 (actual)
Study completion: 9 Jul 2010 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 26 Feb 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Nebivolol	Active comparator	Drug: Nebivolol with concomitant losartan or lisinoprilNebivolol with concomitant losartan or lisinopril
Hydrochlorothiazide (HCTZ)	Active comparator	Drug: HCTZ with concomitant losartan or lisinoprilHCTZ with concomitant losartan or lisinopril
Placebo	Placebo comparator	Drug: Placebo with concomitant losartan or lisinoprilPlacebo with concomitant losartan or lisinopril

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 or female, ambulatory outpatients 18-80 years old at screening.
Have a history of hypertension and taking up to 2 medications for high blood pressure.
Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion

Key exclusion criteria (4 listed)

Have clinically significant respiratory, liver or cardiovascular disease
Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.

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
Nebivolol with concomitant losartan or lisinoprilEncapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.	Drug	Nebivolol
HCTZ with concomitant losartan or lisinoprilEncapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.	Drug	Hydrochlorothiazide (HCTZ)
Placebo with concomitant losartan or lisinoprilPlacebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.	Drug	Placebo

Primary outcome

Trough Seated Diastolic Blood Pressure
Time frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

1 secondary outcome

Plasma Glucose Level After an Oral Glucose Tolerance Test
Time frame: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)

Results and safety

Results posted to the registry on 26 Feb 2020, 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	223	178
Hydrochlorothiazide (HCTZ)	212	174
Placebo	102	90

Primary outcome: Trough Seated Diastolic Blood Pressure

Time frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12). Mean (Standard Deviation). Unit: mm Hg

Measure	Nebivolol n = 217	Placebo n = 100
Value	-9.4 (8.9)	-5.0 (9.5)

Population analysed: The between-treatment-group comparison was performed by means of an analysis-of-covariance model with treatment group and study center as factors and baseline value as a covariate based on Intent-to-Treat (ITT) population. As pre-specified in the protocol, the change in seated DBP was performed between the nebivolol and placebo group.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	5 of 223 (2.2%)	35 of 223 (15.7%)	Not reported
Hydrochlorothiazide (HCTZ)	6 of 212 (2.8%)	21 of 212 (9.9%)	Not reported
Placebo	2 of 102 (2%)	14 of 102 (13.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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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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Enrolling by invitation
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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.

John Shea, MS study director

Forest Research Institute, a subdisiary of Forest Laboratories, Inc.

88 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 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 Feb 2020). 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 (time frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (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 NCT00673790.

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 Feb 2020.